Trial Outcomes & Findings for A Study of LY3502970 in Healthy Participants (NCT NCT03929744)
NCT ID: NCT03929744
Last Updated: 2026-07-10
Results Overview
An SAE is any adverse event from this study that results in 1 of the following: Death, initial or prolonged inpatient hospitalization, a life-threatening experience (that is, immediate risk of dying), persistent or significant disability/incapacity, congenital anomaly/birth defect, important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the subject or may require intervention to prevent 1 of the other outcomes listed in the definition above. The number of participants with one or more SAEs considered by the investigator to be related to study drug administration is reported. An overall summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
133 participants
Primary outcome timeframe
Baseline through Follow-up (up to Day 42)
Results posted on
2026-07-10
Participant Flow
Participant milestones
| Measure |
Part A Placebo
Participants received a single oral dose of Placebo.
|
Part A 0.3 mg LY3502970
Participants received a single oral dose of 0.3 milligram (mg) LY3502970.
|
Part A 1 mg LY3502970
Participants received a single oral dose of 1 mg LY3502970.
|
Part A 3 mg LY3502970
Participants received a single oral dose of 3 mg LY3502970.
|
Part A 6 mg LY3502970
Participants received a single oral dose of 6 mg LY3502970.
|
Part B Placebo
Participants received oral doses of placebo once daily for 4 weeks.
|
Part B: 2 mg LY3502970 (Cohort G)
Participants received oral doses of 2 mg LY3502970 once daily for 4 weeks.
|
Part B: 2 / 4 / 6 mg LY3502970 (Cohort H)
Participants received oral doses of LY3502970 once daily for 4 weeks where 2 mg was given for first week, 4 mg for second week followed by 6 mg on the third and fourth week.
|
Part B: 2 / 4 / 8 / 16 mg LY3502970 (Cohort I)
Participants received oral doses of LY3502970 once daily for 4 weeks where 2 mg was given for first week, 4 mg for second week, 8 mg for third week and 16 mg for fourth week.
|
Part B: 2 / 5 / 12 / 24 mg LY3502970 (Cohort J)
Participants received oral doses of LY3502970 once daily for 4 weeks, where 2 mg was given on first week, 5 mg on second week, 12 mg on third week and 24 mg on fourth week. On day 27, midazolam 200 microgram (mcg) was coadministered with 24 mg LY3502970, and 40 mg atorvastatin administered 4 hours after midazolam.
|
Part B: 2 / 5 / 12 / 24 mg LY3502970 (Cohort K)
Participants received oral doses of LY3502970 once daily for 4 weeks, where 2 mg was given on first week, 5 mg on second week, 12 mg on third week and 24 mg on fourth week. On day 27, 20 mg simvastatin was coadministered with 24 mg LY3502970.
|
Part C: 3 mg LY3502970 (Fasted/Fed)
Participants received a single oral dose of 3 mg LY3502970 in treatment period 1 (fasted condition), followed by administration in treatment period 2 (fed condition), with a washout period of at least 5 days between periods.
|
Part C: 3 mg LY3502970 (Fed/Fasted)
Participants received a single oral dose of 3 mg LY3502970 in treatment period1 (fed condition), followed by administration in treatment period 2 (fasted condition), with a washout period of at least 5 days between periods.
|
Part D: 3 mg LY3502970 Prototype Formulation
Participants received a single oral dose of 3 mg LY3502970 in a controlled-release prototype formulation.
|
Part D: Placebo Prototype Formulation
Participants received a single oral dose of placebo in a controlled-release prototype formulation.
|
Part E: 2 / 5 / 12 / 24 mg LY3502970 (24 mg as Formulation 1)
Participants received oral doses of LY3502970 once daily for 4 weeks where 2 mg was given for first week, 5 mg for second week, 12 mg for third week and 24 mg as formulation 1 for the fourth week.
|
Part E: 2 / 5 / 12 / 24 mg LY3502970 (24 mg as Formulation 2)
Participants received oral doses of LY3502970 once daily for 4 weeks where 2 mg was given for first week, 5 mg for second week, 12 mg for third week and 24 mg as formulation 2 for the fourth week.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
6
|
6
|
6
|
6
|
15
|
9
|
9
|
9
|
9
|
9
|
6
|
6
|
6
|
2
|
11
|
10
|
|
Overall Study
Received at Least One Dose of Study Drug
|
8
|
6
|
6
|
6
|
6
|
15
|
9
|
9
|
9
|
9
|
9
|
6
|
6
|
6
|
2
|
11
|
10
|
|
Overall Study
COMPLETED
|
8
|
6
|
6
|
4
|
6
|
13
|
8
|
8
|
7
|
9
|
8
|
6
|
6
|
5
|
2
|
9
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
2
|
0
|
2
|
1
|
1
|
2
|
0
|
1
|
0
|
0
|
1
|
0
|
2
|
0
|
Reasons for withdrawal
| Measure |
Part A Placebo
Participants received a single oral dose of Placebo.
|
Part A 0.3 mg LY3502970
Participants received a single oral dose of 0.3 milligram (mg) LY3502970.
|
Part A 1 mg LY3502970
Participants received a single oral dose of 1 mg LY3502970.
|
Part A 3 mg LY3502970
Participants received a single oral dose of 3 mg LY3502970.
|
Part A 6 mg LY3502970
Participants received a single oral dose of 6 mg LY3502970.
|
Part B Placebo
Participants received oral doses of placebo once daily for 4 weeks.
|
Part B: 2 mg LY3502970 (Cohort G)
Participants received oral doses of 2 mg LY3502970 once daily for 4 weeks.
|
Part B: 2 / 4 / 6 mg LY3502970 (Cohort H)
Participants received oral doses of LY3502970 once daily for 4 weeks where 2 mg was given for first week, 4 mg for second week followed by 6 mg on the third and fourth week.
|
Part B: 2 / 4 / 8 / 16 mg LY3502970 (Cohort I)
Participants received oral doses of LY3502970 once daily for 4 weeks where 2 mg was given for first week, 4 mg for second week, 8 mg for third week and 16 mg for fourth week.
|
Part B: 2 / 5 / 12 / 24 mg LY3502970 (Cohort J)
Participants received oral doses of LY3502970 once daily for 4 weeks, where 2 mg was given on first week, 5 mg on second week, 12 mg on third week and 24 mg on fourth week. On day 27, midazolam 200 microgram (mcg) was coadministered with 24 mg LY3502970, and 40 mg atorvastatin administered 4 hours after midazolam.
|
Part B: 2 / 5 / 12 / 24 mg LY3502970 (Cohort K)
Participants received oral doses of LY3502970 once daily for 4 weeks, where 2 mg was given on first week, 5 mg on second week, 12 mg on third week and 24 mg on fourth week. On day 27, 20 mg simvastatin was coadministered with 24 mg LY3502970.
|
Part C: 3 mg LY3502970 (Fasted/Fed)
Participants received a single oral dose of 3 mg LY3502970 in treatment period 1 (fasted condition), followed by administration in treatment period 2 (fed condition), with a washout period of at least 5 days between periods.
|
Part C: 3 mg LY3502970 (Fed/Fasted)
Participants received a single oral dose of 3 mg LY3502970 in treatment period1 (fed condition), followed by administration in treatment period 2 (fasted condition), with a washout period of at least 5 days between periods.
|
Part D: 3 mg LY3502970 Prototype Formulation
Participants received a single oral dose of 3 mg LY3502970 in a controlled-release prototype formulation.
|
Part D: Placebo Prototype Formulation
Participants received a single oral dose of placebo in a controlled-release prototype formulation.
|
Part E: 2 / 5 / 12 / 24 mg LY3502970 (24 mg as Formulation 1)
Participants received oral doses of LY3502970 once daily for 4 weeks where 2 mg was given for first week, 5 mg for second week, 12 mg for third week and 24 mg as formulation 1 for the fourth week.
|
Part E: 2 / 5 / 12 / 24 mg LY3502970 (24 mg as Formulation 2)
Participants received oral doses of LY3502970 once daily for 4 weeks where 2 mg was given for first week, 5 mg for second week, 12 mg for third week and 24 mg as formulation 2 for the fourth week.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
2
|
0
|
1
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Study of LY3502970 in Healthy Participants
Baseline characteristics by cohort
| Measure |
Total
n=133 Participants
Total of all reporting groups
|
Part A Placebo
n=8 Participants
Participants received a single oral dose of Placebo.
|
Part A 0.3 mg LY3502970
n=6 Participants
Participants received a single oral dose of 0.3 mg LY3502970.
|
Part A 1 mg LY3502970
n=6 Participants
Participants received a single oral dose of 1 mg LY3502970.
|
Part A 3 mg LY3502970
n=6 Participants
Participants received a single oral dose of 3 mg LY3502970.
|
Part A 6 mg LY3502970
n=6 Participants
Participants received a single oral dose of 6 mg LY3502970.
|
Part B Placebo
n=15 Participants
Participants received oral doses of placebo once daily for 4 weeks.
|
Part B: 2 mg LY3502970 (Cohort G)
n=9 Participants
Participants received oral doses of 2 mg LY3502970 once daily for 4 weeks.
|
Part B: 2 / 4 / 6 mg LY3502970 (Cohort H)
n=9 Participants
Participants received oral doses of LY3502970 once daily for 4 weeks where 2 mg was given for first week, 4 mg for second week followed by 6 mg on the third and fourth week.
|
Part B: 2 / 4 / 8 / 16 mg LY3502970 (Cohort I)
n=9 Participants
Participants received oral doses of LY3502970 once daily for 4 weeks where 2 mg was given for first week, 4 mg for second week, 8 mg for third week and 16 mg for fourth week.
|
Part B: 2 / 5/ 12 / 24 mg LY3502970 (Cohort J)
n=9 Participants
Participants received oral doses of LY3502970 once daily for 4 weeks, where 2 mg was given on first week, 5 mg on second week, 12 mg on third week and 24 mg on fourth week. On day 27, midazolam 200 mcg was coadministered with 24 mg LY3502970, and 40 mg atorvastatin administered 4 hours after midazolam.
|
Part B: 2 / 5/ 12 / 24 mg LY3502970 (Cohort K)
n=9 Participants
Participants received oral doses of LY3502970 once daily for 4 weeks, where 2 mg was given on first week, 5 mg on second week, 12 mg on third week and 24 mg on fourth week. On day 27, 20 mg simvastatin was coadministered with 24 mg LY3502970.
|
Part C: 3 mg LY3502970 (Fasted/Fed)
n=6 Participants
Participants received a single oral dose of 3 mg LY3502970 in treatment period 1 (fasted condition), followed by administration in treatment period 2 (fed condition), with a washout period of at least 5 days between periods.
|
Part C: 3 mg LY3502970 (Fed/Fasted)
n=6 Participants
Participants received a single oral dose of 3 mg LY3502970 in treatment period1 (fed condition), followed by administration in treatment period 2 (fasted condition), with a washout period of at least 5 days between periods.
|
Part D: 3 mg LY3502970 Prototype Formulation
n=6 Participants
Participants received a single oral dose of 3 mg LY3502970 in a controlled-release prototype formulation.
|
Part D: Placebo Prototype Formulation
n=2 Participants
Participants received a single oral dose of placebo in a controlled-release prototype formulation.
|
Part E: 2 / 5 / 12 / 24 mg LY3502970 (24 mg as Formulation 1)
n=11 Participants
Participants received oral doses of LY3502970 once daily for 4 weeks where 2 mg was given for first week, 5 mg for second week, 12 mg for third week and 24 mg as formulation 1 for the fourth week.
|
Part E: 2 / 5 / 12 / 24 mg LY3502970 (24 mg as Formulation 2)
n=10 Participants
Participants received oral doses of LY3502970 once daily for 4 weeks where 2 mg was given for first week, 5 mg for second week, 12 mg for third week and 24 mg as formulation 2 for the fourth week.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=16 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=178 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=190 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=14 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
133 Participants
n=16 Participants
|
8 Participants
n=9 Participants
|
6 Participants
n=27 Participants
|
6 Participants
n=267 Participants
|
6 Participants
n=265 Participants
|
6 Participants
n=568 Participants
|
15 Participants
n=22 Participants
|
9 Participants
n=23 Participants
|
9 Participants
n=22 Participants
|
9 Participants
n=178 Participants
|
9 Participants
n=116 Participants
|
9 Participants
n=2 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=190 Participants
|
6 Participants
n=19 Participants
|
2 Participants
n=18 Participants
|
11 Participants
n=18 Participants
|
10 Participants
n=14 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=16 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=178 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=190 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=14 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=16 Participants
|
2 Participants
n=9 Participants
|
3 Participants
n=27 Participants
|
3 Participants
n=267 Participants
|
1 Participants
n=265 Participants
|
4 Participants
n=568 Participants
|
3 Participants
n=22 Participants
|
3 Participants
n=23 Participants
|
2 Participants
n=22 Participants
|
4 Participants
n=178 Participants
|
0 Participants
n=116 Participants
|
4 Participants
n=2 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=190 Participants
|
2 Participants
n=19 Participants
|
1 Participants
n=18 Participants
|
1 Participants
n=18 Participants
|
1 Participants
n=14 Participants
|
|
Sex: Female, Male
Male
|
95 Participants
n=16 Participants
|
6 Participants
n=9 Participants
|
3 Participants
n=27 Participants
|
3 Participants
n=267 Participants
|
5 Participants
n=265 Participants
|
2 Participants
n=568 Participants
|
12 Participants
n=22 Participants
|
6 Participants
n=23 Participants
|
7 Participants
n=22 Participants
|
5 Participants
n=178 Participants
|
9 Participants
n=116 Participants
|
5 Participants
n=2 Participants
|
5 Participants
n=4 Participants
|
3 Participants
n=190 Participants
|
4 Participants
n=19 Participants
|
1 Participants
n=18 Participants
|
10 Participants
n=18 Participants
|
9 Participants
n=14 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
41 Participants
n=16 Participants
|
5 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
1 Participants
n=265 Participants
|
2 Participants
n=568 Participants
|
5 Participants
n=22 Participants
|
2 Participants
n=23 Participants
|
5 Participants
n=22 Participants
|
2 Participants
n=178 Participants
|
2 Participants
n=116 Participants
|
5 Participants
n=2 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=190 Participants
|
1 Participants
n=19 Participants
|
1 Participants
n=18 Participants
|
3 Participants
n=18 Participants
|
1 Participants
n=14 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
92 Participants
n=16 Participants
|
3 Participants
n=9 Participants
|
5 Participants
n=27 Participants
|
5 Participants
n=267 Participants
|
5 Participants
n=265 Participants
|
4 Participants
n=568 Participants
|
10 Participants
n=22 Participants
|
7 Participants
n=23 Participants
|
4 Participants
n=22 Participants
|
7 Participants
n=178 Participants
|
7 Participants
n=116 Participants
|
4 Participants
n=2 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=190 Participants
|
5 Participants
n=19 Participants
|
1 Participants
n=18 Participants
|
8 Participants
n=18 Participants
|
9 Participants
n=14 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=16 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=178 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=190 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=14 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=16 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=178 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=190 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=16 Participants
|
0 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
0 Participants
n=22 Participants
|
1 Participants
n=23 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=178 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=2 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=190 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
1 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=16 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=178 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=190 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Black or African American
|
48 Participants
n=16 Participants
|
1 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
3 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
8 Participants
n=22 Participants
|
4 Participants
n=23 Participants
|
3 Participants
n=22 Participants
|
2 Participants
n=178 Participants
|
4 Participants
n=116 Participants
|
3 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=190 Participants
|
4 Participants
n=19 Participants
|
0 Participants
n=18 Participants
|
6 Participants
n=18 Participants
|
5 Participants
n=14 Participants
|
|
Race (NIH/OMB)
White
|
78 Participants
n=16 Participants
|
7 Participants
n=9 Participants
|
3 Participants
n=27 Participants
|
3 Participants
n=267 Participants
|
6 Participants
n=265 Participants
|
6 Participants
n=568 Participants
|
7 Participants
n=22 Participants
|
4 Participants
n=23 Participants
|
6 Participants
n=22 Participants
|
7 Participants
n=178 Participants
|
3 Participants
n=116 Participants
|
6 Participants
n=2 Participants
|
5 Participants
n=4 Participants
|
3 Participants
n=190 Participants
|
2 Participants
n=19 Participants
|
2 Participants
n=18 Participants
|
4 Participants
n=18 Participants
|
4 Participants
n=14 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=16 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=178 Participants
|
2 Participants
n=116 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=190 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=18 Participants
|
1 Participants
n=18 Participants
|
0 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=16 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=178 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=190 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=14 Participants
|
|
Region of Enrollment
United States
|
133 Participants
n=16 Participants
|
8 Participants
n=9 Participants
|
6 Participants
n=27 Participants
|
6 Participants
n=267 Participants
|
6 Participants
n=265 Participants
|
6 Participants
n=568 Participants
|
15 Participants
n=22 Participants
|
9 Participants
n=23 Participants
|
9 Participants
n=22 Participants
|
9 Participants
n=178 Participants
|
9 Participants
n=116 Participants
|
9 Participants
n=2 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=190 Participants
|
6 Participants
n=19 Participants
|
2 Participants
n=18 Participants
|
11 Participants
n=18 Participants
|
10 Participants
n=14 Participants
|
PRIMARY outcome
Timeframe: Baseline through Follow-up (up to Day 42)Population: All participants in parts A and B who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in part B.
An SAE is any adverse event from this study that results in 1 of the following: Death, initial or prolonged inpatient hospitalization, a life-threatening experience (that is, immediate risk of dying), persistent or significant disability/incapacity, congenital anomaly/birth defect, important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the subject or may require intervention to prevent 1 of the other outcomes listed in the definition above. The number of participants with one or more SAEs considered by the investigator to be related to study drug administration is reported. An overall summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module.
Outcome measures
| Measure |
Part B: 16 mg LY3502970 (Cohort I)
n=6 Participants
Participants received 16 mg LY3502970 on Day 28.
|
Part B: 24 mg LY3502970 (Cohorts J, K)
n=6 Participants
Participants received 24 mg LY3502970 on Day 28.
|
Part B: 2 mg LY3502970 (Cohorts G-K).
n=8 Participants
Participants received 2 mg LY3502970 on Day 1.
|
Part B: 6 mg LY3502970 (Cohort H)
n=6 Participants
Participants received 6 mg LY3502970 on Day 28.
|
Part A 6 mg LY3502970
n=6 Participants
Participants received a single oral dose of 6 mg LY3502970.
|
Part B Placebo
n=15 Participants
Participants received oral doses of placebo once daily for 4 weeks.
|
Part B: 2 mg LY3502970
n=45 Participants
Participants received 2 mg LY3502970 (cohorts G, H, I, J, K).
|
Part B: 4 mg LY3502970
n=18 Participants
Participants received 4 mg LY3502970 (cohorts H, I).
|
Part B: 5 mg LY3502970
n=17 Participants
Participants received 5 mg LY3502970 (cohorts J, K).
|
Part B: 6 mg LY3502970
n=8 Participants
Participants received 6 mg LY3502970 (cohort H).
|
Part B: 8 mg LY3502970
n=9 Participants
Participants received 8 mg LY3502970 (cohort I).
|
Part B: 12 mg LY3502970
n=17 Participants
Participants received 12 mg LY3502970 (cohorts J, K).
|
Part B: 16 mg LY3502970
n=8 Participants
Participants received 16 mg LY3502970 (cohort I).
|
Part B: 24 mg LY3502970
n=17 Participants
Participants received 24 mg LY3502970 (cohorts J, K).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Parts A and B: Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 4, 8, 12, 16, 24, 48, 72, 96 hours post-dosePopulation: Part A: All participants who received at least one dose of LY3502970 and had evaluable PK data.
PK: Cmax of LY3502970
Outcome measures
| Measure |
Part B: 16 mg LY3502970 (Cohort I)
n=4 Participants
Participants received 16 mg LY3502970 on Day 28.
|
Part B: 24 mg LY3502970 (Cohorts J, K)
n=2 Participants
Participants received 24 mg LY3502970 on Day 28.
|
Part B: 2 mg LY3502970 (Cohorts G-K).
n=6 Participants
Participants received 2 mg LY3502970 on Day 1.
|
Part B: 6 mg LY3502970 (Cohort H)
n=6 Participants
Participants received 6 mg LY3502970 on Day 28.
|
Part A 6 mg LY3502970
Participants received a single oral dose of 6 mg LY3502970.
|
Part B Placebo
Participants received oral doses of placebo once daily for 4 weeks.
|
Part B: 2 mg LY3502970
Participants received 2 mg LY3502970 (cohorts G, H, I, J, K).
|
Part B: 4 mg LY3502970
Participants received 4 mg LY3502970 (cohorts H, I).
|
Part B: 5 mg LY3502970
Participants received 5 mg LY3502970 (cohorts J, K).
|
Part B: 6 mg LY3502970
Participants received 6 mg LY3502970 (cohort H).
|
Part B: 8 mg LY3502970
Participants received 8 mg LY3502970 (cohort I).
|
Part B: 12 mg LY3502970
Participants received 12 mg LY3502970 (cohorts J, K).
|
Part B: 16 mg LY3502970
Participants received 16 mg LY3502970 (cohort I).
|
Part B: 24 mg LY3502970
Participants received 24 mg LY3502970 (cohorts J, K).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part A: Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3502970
|
14.9 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 20
|
12.9 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 43
|
1.45 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 48
|
4.02 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 36
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 4, 8, 12, 16, 24, 48, 72, 96 hours post-dosePopulation: Part A: All participants who received at least one dose of LY3502970 and had evaluable PK data.
PK: AUC(0-tlast) of LY3502970
Outcome measures
| Measure |
Part B: 16 mg LY3502970 (Cohort I)
n=4 Participants
Participants received 16 mg LY3502970 on Day 28.
|
Part B: 24 mg LY3502970 (Cohorts J, K)
n=2 Participants
Participants received 24 mg LY3502970 on Day 28.
|
Part B: 2 mg LY3502970 (Cohorts G-K).
n=6 Participants
Participants received 2 mg LY3502970 on Day 1.
|
Part B: 6 mg LY3502970 (Cohort H)
n=6 Participants
Participants received 6 mg LY3502970 on Day 28.
|
Part A 6 mg LY3502970
Participants received a single oral dose of 6 mg LY3502970.
|
Part B Placebo
Participants received oral doses of placebo once daily for 4 weeks.
|
Part B: 2 mg LY3502970
Participants received 2 mg LY3502970 (cohorts G, H, I, J, K).
|
Part B: 4 mg LY3502970
Participants received 4 mg LY3502970 (cohorts H, I).
|
Part B: 5 mg LY3502970
Participants received 5 mg LY3502970 (cohorts J, K).
|
Part B: 6 mg LY3502970
Participants received 6 mg LY3502970 (cohort H).
|
Part B: 8 mg LY3502970
Participants received 8 mg LY3502970 (cohort I).
|
Part B: 12 mg LY3502970
Participants received 12 mg LY3502970 (cohorts J, K).
|
Part B: 16 mg LY3502970
Participants received 16 mg LY3502970 (cohort I).
|
Part B: 24 mg LY3502970
Participants received 24 mg LY3502970 (cohorts J, K).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part A: PK: Area Under the Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration (AUC[0-tlast]) of LY3502970
|
362 nanograms*hours per milliliter (ng*h/mL)
Geometric Coefficient of Variation 28
|
440 nanograms*hours per milliliter (ng*h/mL)
Geometric Coefficient of Variation 8
|
34.0 nanograms*hours per milliliter (ng*h/mL)
Geometric Coefficient of Variation 41
|
89.1 nanograms*hours per milliliter (ng*h/mL)
Geometric Coefficient of Variation 54
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 4, 8, 12, 16, 24, 48, 72, 96 hours post-dosePopulation: Part A: All participants who received at least one dose of LY3502970 and had evaluable PK data.
PK: Tmax of LY3502970
Outcome measures
| Measure |
Part B: 16 mg LY3502970 (Cohort I)
n=4 Participants
Participants received 16 mg LY3502970 on Day 28.
|
Part B: 24 mg LY3502970 (Cohorts J, K)
n=2 Participants
Participants received 24 mg LY3502970 on Day 28.
|
Part B: 2 mg LY3502970 (Cohorts G-K).
n=6 Participants
Participants received 2 mg LY3502970 on Day 1.
|
Part B: 6 mg LY3502970 (Cohort H)
n=6 Participants
Participants received 6 mg LY3502970 on Day 28.
|
Part A 6 mg LY3502970
Participants received a single oral dose of 6 mg LY3502970.
|
Part B Placebo
Participants received oral doses of placebo once daily for 4 weeks.
|
Part B: 2 mg LY3502970
Participants received 2 mg LY3502970 (cohorts G, H, I, J, K).
|
Part B: 4 mg LY3502970
Participants received 4 mg LY3502970 (cohorts H, I).
|
Part B: 5 mg LY3502970
Participants received 5 mg LY3502970 (cohorts J, K).
|
Part B: 6 mg LY3502970
Participants received 6 mg LY3502970 (cohort H).
|
Part B: 8 mg LY3502970
Participants received 8 mg LY3502970 (cohort I).
|
Part B: 12 mg LY3502970
Participants received 12 mg LY3502970 (cohorts J, K).
|
Part B: 16 mg LY3502970
Participants received 16 mg LY3502970 (cohort I).
|
Part B: 24 mg LY3502970
Participants received 24 mg LY3502970 (cohorts J, K).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part A: PK: Time of Maximum Observed Concentration (Tmax) of LY3502970
|
6.04 hours
Interval 4.05 to 8.0
|
12.04 hours
Interval 8.07 to 16.02
|
8 hours
Interval 4.05 to 16.15
|
4.05 hours
Interval 4.05 to 8.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (pre-dose, 0.5, 1, 2, 4, 8, 12, 16, 24 hours post-dose)Population: Part B: All participants who received LY3502970 on Day 1 and had evaluable PK data. Per protocol, PK analysis was conducted by treatment dose. On day 1, participants in all the cohorts (G-K) received 2 mg LY3502970, therefore, Cmax of LY3502970 for the 2 mg treatment dose was reported.
PK: Cmax of LY3502970
Outcome measures
| Measure |
Part B: 16 mg LY3502970 (Cohort I)
Participants received 16 mg LY3502970 on Day 28.
|
Part B: 24 mg LY3502970 (Cohorts J, K)
Participants received 24 mg LY3502970 on Day 28.
|
Part B: 2 mg LY3502970 (Cohorts G-K).
n=45 Participants
Participants received 2 mg LY3502970 on Day 1.
|
Part B: 6 mg LY3502970 (Cohort H)
Participants received 6 mg LY3502970 on Day 28.
|
Part A 6 mg LY3502970
Participants received a single oral dose of 6 mg LY3502970.
|
Part B Placebo
Participants received oral doses of placebo once daily for 4 weeks.
|
Part B: 2 mg LY3502970
Participants received 2 mg LY3502970 (cohorts G, H, I, J, K).
|
Part B: 4 mg LY3502970
Participants received 4 mg LY3502970 (cohorts H, I).
|
Part B: 5 mg LY3502970
Participants received 5 mg LY3502970 (cohorts J, K).
|
Part B: 6 mg LY3502970
Participants received 6 mg LY3502970 (cohort H).
|
Part B: 8 mg LY3502970
Participants received 8 mg LY3502970 (cohort I).
|
Part B: 12 mg LY3502970
Participants received 12 mg LY3502970 (cohorts J, K).
|
Part B: 16 mg LY3502970
Participants received 16 mg LY3502970 (cohort I).
|
Part B: 24 mg LY3502970
Participants received 24 mg LY3502970 (cohorts J, K).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part B: PK: Maximum Observed Concentration (Cmax) of LY3502970 on Day 1
|
—
|
—
|
8.40 ng/mL
Geometric Coefficient of Variation 33
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 28 (pre-dose, 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 96, 168, 336 hours post-dose)Population: Part B: All participants who received LY3502970 on Day 28 and had evaluable PK data. Per protocol, PK analysis was conducted by treatment dose. On Day 28, participants in cohort G received 2 mg, H received 6 mg, I received 16 mg, J and K received 24 mg of LY3502970. Therefore, Cmax of LY3502970 for the respective treatment doses were reported.
PK: Cmax of LY3502970
Outcome measures
| Measure |
Part B: 16 mg LY3502970 (Cohort I)
n=8 Participants
Participants received 16 mg LY3502970 on Day 28.
|
Part B: 24 mg LY3502970 (Cohorts J, K)
n=17 Participants
Participants received 24 mg LY3502970 on Day 28.
|
Part B: 2 mg LY3502970 (Cohorts G-K).
n=9 Participants
Participants received 2 mg LY3502970 on Day 1.
|
Part B: 6 mg LY3502970 (Cohort H)
n=8 Participants
Participants received 6 mg LY3502970 on Day 28.
|
Part A 6 mg LY3502970
Participants received a single oral dose of 6 mg LY3502970.
|
Part B Placebo
Participants received oral doses of placebo once daily for 4 weeks.
|
Part B: 2 mg LY3502970
Participants received 2 mg LY3502970 (cohorts G, H, I, J, K).
|
Part B: 4 mg LY3502970
Participants received 4 mg LY3502970 (cohorts H, I).
|
Part B: 5 mg LY3502970
Participants received 5 mg LY3502970 (cohorts J, K).
|
Part B: 6 mg LY3502970
Participants received 6 mg LY3502970 (cohort H).
|
Part B: 8 mg LY3502970
Participants received 8 mg LY3502970 (cohort I).
|
Part B: 12 mg LY3502970
Participants received 12 mg LY3502970 (cohorts J, K).
|
Part B: 16 mg LY3502970
Participants received 16 mg LY3502970 (cohort I).
|
Part B: 24 mg LY3502970
Participants received 24 mg LY3502970 (cohorts J, K).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part B: PK: Maximum Observed Concentration (Cmax) of LY3502970 on Day 28
|
68.2 ng/mL
Geometric Coefficient of Variation 51
|
99.6 ng/mL
Geometric Coefficient of Variation 92
|
11.1 ng/mL
Geometric Coefficient of Variation 36
|
34.4 ng/mL
Geometric Coefficient of Variation 23
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (pre-dose, 0.5, 1, 2, 4, 8, 12, 16, 24 hours post-dose)Population: Part B: All participants who received LY3502970 on Day 1 and had evaluable PK data. Per protocol, PK analysis was conducted by treatment dose. On day 1, participants in all the cohorts (G-K) received 2 mg LY3502970, therefore, AUC(0-tlast) of LY3502970 for the 2 mg treatment dose was reported.
PK: AUC(0-tlast) of LY3502970
Outcome measures
| Measure |
Part B: 16 mg LY3502970 (Cohort I)
Participants received 16 mg LY3502970 on Day 28.
|
Part B: 24 mg LY3502970 (Cohorts J, K)
Participants received 24 mg LY3502970 on Day 28.
|
Part B: 2 mg LY3502970 (Cohorts G-K).
n=45 Participants
Participants received 2 mg LY3502970 on Day 1.
|
Part B: 6 mg LY3502970 (Cohort H)
Participants received 6 mg LY3502970 on Day 28.
|
Part A 6 mg LY3502970
Participants received a single oral dose of 6 mg LY3502970.
|
Part B Placebo
Participants received oral doses of placebo once daily for 4 weeks.
|
Part B: 2 mg LY3502970
Participants received 2 mg LY3502970 (cohorts G, H, I, J, K).
|
Part B: 4 mg LY3502970
Participants received 4 mg LY3502970 (cohorts H, I).
|
Part B: 5 mg LY3502970
Participants received 5 mg LY3502970 (cohorts J, K).
|
Part B: 6 mg LY3502970
Participants received 6 mg LY3502970 (cohort H).
|
Part B: 8 mg LY3502970
Participants received 8 mg LY3502970 (cohort I).
|
Part B: 12 mg LY3502970
Participants received 12 mg LY3502970 (cohorts J, K).
|
Part B: 16 mg LY3502970
Participants received 16 mg LY3502970 (cohort I).
|
Part B: 24 mg LY3502970
Participants received 24 mg LY3502970 (cohorts J, K).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part B: PK: Area Under the Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration (AUC[0-tlast]) of LY3502970 on Day 1
|
—
|
—
|
118 ng*h/mL
Geometric Coefficient of Variation 29
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 28 (pre-dose, 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 96, 168, 336 hours post-dose)Population: Part B: All participants who received LY3502970 on Day 28 and had evaluable PK data. Per protocol, PK analysis was conducted by treatment dose. On Day 28, participants in cohort G received 2 mg, H received 6 mg, I received 16 mg, J and K received 24 mg of LY3502970. Therefore, AUC(0-tlast) of LY3502970 for the respective treatment doses were reported.
PK: AUC(0-tlast) of LY3502970
Outcome measures
| Measure |
Part B: 16 mg LY3502970 (Cohort I)
n=8 Participants
Participants received 16 mg LY3502970 on Day 28.
|
Part B: 24 mg LY3502970 (Cohorts J, K)
n=17 Participants
Participants received 24 mg LY3502970 on Day 28.
|
Part B: 2 mg LY3502970 (Cohorts G-K).
n=9 Participants
Participants received 2 mg LY3502970 on Day 1.
|
Part B: 6 mg LY3502970 (Cohort H)
n=8 Participants
Participants received 6 mg LY3502970 on Day 28.
|
Part A 6 mg LY3502970
Participants received a single oral dose of 6 mg LY3502970.
|
Part B Placebo
Participants received oral doses of placebo once daily for 4 weeks.
|
Part B: 2 mg LY3502970
Participants received 2 mg LY3502970 (cohorts G, H, I, J, K).
|
Part B: 4 mg LY3502970
Participants received 4 mg LY3502970 (cohorts H, I).
|
Part B: 5 mg LY3502970
Participants received 5 mg LY3502970 (cohorts J, K).
|
Part B: 6 mg LY3502970
Participants received 6 mg LY3502970 (cohort H).
|
Part B: 8 mg LY3502970
Participants received 8 mg LY3502970 (cohort I).
|
Part B: 12 mg LY3502970
Participants received 12 mg LY3502970 (cohorts J, K).
|
Part B: 16 mg LY3502970
Participants received 16 mg LY3502970 (cohort I).
|
Part B: 24 mg LY3502970
Participants received 24 mg LY3502970 (cohorts J, K).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part B: PK: Area Under the Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration (AUC[0-tlast]) of LY3502970 on Day 28
|
3080 ng*h/mL
Geometric Coefficient of Variation 60
|
3490 ng*h/mL
Geometric Coefficient of Variation 90
|
428 ng*h/mL
Geometric Coefficient of Variation 43
|
1300 ng*h/mL
Geometric Coefficient of Variation 68
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (pre-dose, 0.5, 1, 2, 4, 8, 12, 16, 24 hours post-dose)Population: Part B: All participants who received LY3502970 on Day 1 and had evaluable PK data. Per protocol, PK analysis was conducted by treatment dose. On day 1, participants in all the cohorts (G-K) received 2 mg LY3502970, therefore, Tmax of LY3502970 for the 2 mg treatment dose was reported.
PK: Tmax of LY3502970
Outcome measures
| Measure |
Part B: 16 mg LY3502970 (Cohort I)
Participants received 16 mg LY3502970 on Day 28.
|
Part B: 24 mg LY3502970 (Cohorts J, K)
Participants received 24 mg LY3502970 on Day 28.
|
Part B: 2 mg LY3502970 (Cohorts G-K).
n=45 Participants
Participants received 2 mg LY3502970 on Day 1.
|
Part B: 6 mg LY3502970 (Cohort H)
Participants received 6 mg LY3502970 on Day 28.
|
Part A 6 mg LY3502970
Participants received a single oral dose of 6 mg LY3502970.
|
Part B Placebo
Participants received oral doses of placebo once daily for 4 weeks.
|
Part B: 2 mg LY3502970
Participants received 2 mg LY3502970 (cohorts G, H, I, J, K).
|
Part B: 4 mg LY3502970
Participants received 4 mg LY3502970 (cohorts H, I).
|
Part B: 5 mg LY3502970
Participants received 5 mg LY3502970 (cohorts J, K).
|
Part B: 6 mg LY3502970
Participants received 6 mg LY3502970 (cohort H).
|
Part B: 8 mg LY3502970
Participants received 8 mg LY3502970 (cohort I).
|
Part B: 12 mg LY3502970
Participants received 12 mg LY3502970 (cohorts J, K).
|
Part B: 16 mg LY3502970
Participants received 16 mg LY3502970 (cohort I).
|
Part B: 24 mg LY3502970
Participants received 24 mg LY3502970 (cohorts J, K).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part B: PK: Time of Maximum Observed Concentration (Tmax) of LY3502970 on Day 1
|
—
|
—
|
8 hours
Interval 3.92 to 12.02
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 28 (pre-dose, 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 96, 168, 336 hours post-dose)Population: Part B: All participants who received LY3502970 on Day 28 and had evaluable PK data. Per protocol, PK analysis was conducted by treatment dose. On Day 28, participants in cohort G received 2 mg, H received 6 mg, I received 16 mg, J and K received 24 mg of LY3502970. Therefore, Tmax of LY3502970 for the respective treatment doses were reported.
PK: Tmax of LY3502970
Outcome measures
| Measure |
Part B: 16 mg LY3502970 (Cohort I)
n=8 Participants
Participants received 16 mg LY3502970 on Day 28.
|
Part B: 24 mg LY3502970 (Cohorts J, K)
n=17 Participants
Participants received 24 mg LY3502970 on Day 28.
|
Part B: 2 mg LY3502970 (Cohorts G-K).
n=9 Participants
Participants received 2 mg LY3502970 on Day 1.
|
Part B: 6 mg LY3502970 (Cohort H)
n=8 Participants
Participants received 6 mg LY3502970 on Day 28.
|
Part A 6 mg LY3502970
Participants received a single oral dose of 6 mg LY3502970.
|
Part B Placebo
Participants received oral doses of placebo once daily for 4 weeks.
|
Part B: 2 mg LY3502970
Participants received 2 mg LY3502970 (cohorts G, H, I, J, K).
|
Part B: 4 mg LY3502970
Participants received 4 mg LY3502970 (cohorts H, I).
|
Part B: 5 mg LY3502970
Participants received 5 mg LY3502970 (cohorts J, K).
|
Part B: 6 mg LY3502970
Participants received 6 mg LY3502970 (cohort H).
|
Part B: 8 mg LY3502970
Participants received 8 mg LY3502970 (cohort I).
|
Part B: 12 mg LY3502970
Participants received 12 mg LY3502970 (cohorts J, K).
|
Part B: 16 mg LY3502970
Participants received 16 mg LY3502970 (cohort I).
|
Part B: 24 mg LY3502970
Participants received 24 mg LY3502970 (cohorts J, K).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part B: PK: Time of Maximum Observed Concentration (Tmax) of LY3502970 on Day 28
|
6.06 hours
Interval 2.0 to 12.13
|
8.08 hours
Interval 0.0 to 24.0
|
4.08 hours
Interval 2.0 to 8.0
|
8.00 hours
Interval 4.07 to 12.17
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Part A Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part A 0.3 mg LY3502970
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part A 1 mg LY3502970
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part A 3 mg LY3502970
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part A 6 mg LY3502970
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Part B Placebo QD
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Part B 2 mg LY3502970 QD
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Part B 4 mg LY3502970 QD
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Part B 5 mg LY3502970 QD
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Part B 6 mg LY3502970 QD
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Part B 8 mg LY3502970 QD
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Part B 12 mg LY3502970 QD
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Part B 16 mg LY3502970 QD
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part B 24 mg LY3502970 QD
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Part C 3 mg LY3502970 Fasted
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part C 3 mg LY3502970 Fed
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part D: 3 mg LY3502970 Prototype Formulation
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part D: Placebo Prototype Formulation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part E 2 mg LY3502970 QD
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Part E 5 mg LY3502970 QD
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Part E 12 mg LY3502970 QD
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Part E 24 mg LY3502970 QD
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Part E 24 mg LY3502970 Formulation 1 QD
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part E 24 mg LY3502970 Formulation 2 QD
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Part A Placebo
n=8 participants at risk
Participants received a single oral dose of Placebo.
|
Part A 0.3 mg LY3502970
n=6 participants at risk
Participants received a single oral dose of 0.3 mg LY3502970.
|
Part A 1 mg LY3502970
n=6 participants at risk
Participants received a single oral dose of 1 mg LY3502970.
|
Part A 3 mg LY3502970
n=6 participants at risk
Participants received a single oral dose of 3 mg LY3502970.
|
Part A 6 mg LY3502970
n=6 participants at risk
Participants received a single oral dose of 6 mg LY3502970.
|
Part B Placebo QD
n=15 participants at risk
Participants received oral doses of placebo once daily for 4 weeks.
|
Part B 2 mg LY3502970 QD
n=45 participants at risk
Participants received 2 mg LY3502970 (cohorts G, H, I, J, K).
|
Part B 4 mg LY3502970 QD
n=18 participants at risk
Participants received 4 mg LY3502970 (cohorts H, I).
|
Part B 5 mg LY3502970 QD
n=17 participants at risk
Participants received 5 mg LY3502970 (cohorts J, K).
|
Part B 6 mg LY3502970 QD
n=8 participants at risk
Participants received 6 mg LY3502970 (cohort H).
|
Part B 8 mg LY3502970 QD
n=9 participants at risk
Participants received 8 mg LY3502970 (cohort I).
|
Part B 12 mg LY3502970 QD
n=17 participants at risk
Participants received 12 mg LY3502970 (cohorts J, K).
|
Part B 16 mg LY3502970 QD
n=8 participants at risk
Participants received 16 mg LY3502970 (cohort I).
|
Part B 24 mg LY3502970 QD
n=17 participants at risk
Participants received 24 mg LY3502970 (cohorts J, K).
|
Part C 3 mg LY3502970 Fasted
n=12 participants at risk
Participants received a 3 mg LY3502970 in fasted conditions.
|
Part C 3 mg LY3502970 Fed
n=12 participants at risk
Participants received a 3 mg LY3502970 in fed conditions.
|
Part D: 3 mg LY3502970 Prototype Formulation
n=6 participants at risk
Participants received a single oral dose of 3 mg LY3502970 in a controlled-release prototype formulation.
|
Part D: Placebo Prototype Formulation
n=2 participants at risk
Participants received a single oral dose of placebo in a controlled-release prototype formulation.
|
Part E 2 mg LY3502970 QD
n=21 participants at risk
Participants received 2 mg LY3502970.
|
Part E 5 mg LY3502970 QD
n=20 participants at risk
Participants received 5 mg LY3502970.
|
Part E 12 mg LY3502970 QD
n=19 participants at risk
Participants received 12 mg LY3502970.
|
Part E 24 mg LY3502970 QD
n=19 participants at risk
Participants received 24 mg LY3502970 as either formulation 1 or formulation 2.
|
Part E 24 mg LY3502970 Formulation 1 QD
n=9 participants at risk
Participants received 24 mg LY3502970 as formulation 1.
|
Part E 24 mg LY3502970 Formulation 2 QD
n=10 participants at risk
Participants received 24 mg LY3502970 as formulation 2.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/8 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/15 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
2.2%
1/45 • Number of events 1 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/18 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/17 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/8 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
5.9%
1/17 • Number of events 1 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/8 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
5.9%
1/17 • Number of events 1 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/12 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/12 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
16.7%
1/6 • Number of events 1 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/2 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
4.8%
1/21 • Number of events 1 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/20 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/19 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
5.3%
1/19 • Number of events 1 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/10 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/8 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
16.7%
1/6 • Number of events 1 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/15 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
13.3%
6/45 • Number of events 6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
5.6%
1/18 • Number of events 1 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/17 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
12.5%
1/8 • Number of events 1 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/17 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/8 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
5.9%
1/17 • Number of events 1 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/12 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/12 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/2 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
4.8%
1/21 • Number of events 1 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/20 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/19 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/19 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/10 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/8 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/15 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/45 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/18 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/17 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/8 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/17 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/8 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/17 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/12 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/12 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
16.7%
1/6 • Number of events 1 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/2 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/21 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/20 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/19 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/19 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/10 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/8 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/15 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/45 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/18 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/17 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/8 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/17 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/8 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/17 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
8.3%
1/12 • Number of events 1 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/12 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/2 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/21 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/20 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/19 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/19 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/10 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/8 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/15 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
11.1%
5/45 • Number of events 5 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
33.3%
6/18 • Number of events 6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
17.6%
3/17 • Number of events 3 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
12.5%
1/8 • Number of events 1 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
22.2%
2/9 • Number of events 2 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
11.8%
2/17 • Number of events 2 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/8 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
11.8%
2/17 • Number of events 2 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/12 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/12 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
16.7%
1/6 • Number of events 1 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/2 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/21 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
5.0%
1/20 • Number of events 1 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/19 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/19 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/10 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/8 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/15 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
2.2%
1/45 • Number of events 2 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/18 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/17 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/8 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/17 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
12.5%
1/8 • Number of events 1 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/17 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/12 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/12 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/2 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/21 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/20 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/19 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/19 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/10 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/8 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/15 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/45 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/18 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
5.9%
1/17 • Number of events 1 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
12.5%
1/8 • Number of events 1 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
5.9%
1/17 • Number of events 2 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/8 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/17 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/12 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/12 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/2 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
4.8%
1/21 • Number of events 1 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
5.0%
1/20 • Number of events 1 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
5.3%
1/19 • Number of events 1 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/19 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/10 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/8 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/15 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/45 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/18 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
5.9%
1/17 • Number of events 1 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/8 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/17 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/8 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/17 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/12 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/12 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/2 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/21 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/20 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
5.3%
1/19 • Number of events 1 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
5.3%
1/19 • Number of events 1 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/10 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/8 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
6.7%
1/15 • Number of events 1 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/45 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/18 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/17 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/8 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/17 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/8 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/17 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/12 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/12 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/2 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
4.8%
1/21 • Number of events 1 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/20 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/19 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/19 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/10 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/8 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
16.7%
1/6 • Number of events 1 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/15 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/45 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/18 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/17 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/8 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/17 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/8 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/17 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/12 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/12 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/2 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/21 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/20 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/19 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/19 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/10 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/8 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
50.0%
3/6 • Number of events 4 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
50.0%
3/6 • Number of events 3 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/15 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
11.1%
5/45 • Number of events 5 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
22.2%
4/18 • Number of events 4 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
5.9%
1/17 • Number of events 1 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
50.0%
4/8 • Number of events 4 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
33.3%
3/9 • Number of events 3 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
17.6%
3/17 • Number of events 4 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
12.5%
1/8 • Number of events 1 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
11.8%
2/17 • Number of events 2 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
16.7%
2/12 • Number of events 2 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/12 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
16.7%
1/6 • Number of events 1 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/2 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
9.5%
2/21 • Number of events 2 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
5.0%
1/20 • Number of events 1 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
21.1%
4/19 • Number of events 4 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
15.8%
3/19 • Number of events 3 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
10.0%
1/10 • Number of events 1 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/8 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
50.0%
3/6 • Number of events 7 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
66.7%
4/6 • Number of events 6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/15 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
4.4%
2/45 • Number of events 2 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/18 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/17 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/8 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
11.1%
1/9 • Number of events 1 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
5.9%
1/17 • Number of events 1 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/8 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
17.6%
3/17 • Number of events 5 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
8.3%
1/12 • Number of events 1 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/12 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/2 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
14.3%
3/21 • Number of events 4 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/20 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
15.8%
3/19 • Number of events 4 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
5.3%
1/19 • Number of events 1 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
10.0%
1/10 • Number of events 1 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
|
General disorders
Asthenia
|
0.00%
0/8 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/15 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/45 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/18 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/17 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/8 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
5.9%
1/17 • Number of events 1 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/8 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/17 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/12 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/12 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/2 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/21 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/20 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/19 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/19 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/10 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
|
General disorders
Chest discomfort
|
0.00%
0/8 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/15 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/45 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/18 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/17 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
12.5%
1/8 • Number of events 1 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/17 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/8 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/17 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/12 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/12 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/2 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/21 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/20 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/19 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/19 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/10 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
|
General disorders
Chills
|
0.00%
0/8 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/15 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/45 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/18 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/17 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/8 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/17 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/8 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/17 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/12 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/12 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/2 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/21 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/20 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/19 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
5.3%
1/19 • Number of events 1 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/10 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
|
General disorders
Medical device site irritation
|
0.00%
0/8 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/15 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/45 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/18 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/17 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/8 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
5.9%
1/17 • Number of events 1 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/8 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
5.9%
1/17 • Number of events 1 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/12 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/12 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/2 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/21 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
5.0%
1/20 • Number of events 1 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/19 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/19 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/10 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
|
Infections and infestations
Skin infection
|
0.00%
0/8 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/15 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/45 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/18 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/17 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/8 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/17 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/8 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
5.9%
1/17 • Number of events 1 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/12 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/12 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/2 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/21 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/20 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/19 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/19 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/10 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
|
Investigations
Electrocardiogram t wave inversion
|
0.00%
0/8 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
16.7%
1/6 • Number of events 1 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/15 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/45 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/18 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/17 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/8 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/17 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/8 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/17 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/12 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/12 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/2 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/21 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/20 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/19 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/19 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/10 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/8 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
16.7%
1/6 • Number of events 1 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/15 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
8.9%
4/45 • Number of events 4 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
5.6%
1/18 • Number of events 1 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
5.9%
1/17 • Number of events 1 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
12.5%
1/8 • Number of events 1 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
11.1%
1/9 • Number of events 1 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/17 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/8 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/17 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/12 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/12 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/2 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
9.5%
2/21 • Number of events 2 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/20 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
10.5%
2/19 • Number of events 2 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/19 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/10 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/8 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/15 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/45 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/18 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/17 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/8 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
11.1%
1/9 • Number of events 1 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/17 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/8 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/17 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/12 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/12 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/2 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/21 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/20 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/19 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/19 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/10 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/8 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
6.7%
1/15 • Number of events 2 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
2.2%
1/45 • Number of events 1 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/18 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/17 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/8 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/17 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/8 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/17 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/12 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/12 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/2 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/21 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/20 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/19 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/19 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/10 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/8 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
6.7%
1/15 • Number of events 1 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/45 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/18 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/17 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/8 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/17 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/8 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/17 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/12 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/12 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/2 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/21 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/20 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/19 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/19 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/10 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/8 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
16.7%
1/6 • Number of events 1 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/15 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/45 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/18 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/17 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/8 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/17 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/8 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/17 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/12 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/12 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/2 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/21 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/20 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/19 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/19 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/10 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/8 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/15 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
6.7%
3/45 • Number of events 3 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
11.1%
2/18 • Number of events 2 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/17 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
12.5%
1/8 • Number of events 1 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
5.9%
1/17 • Number of events 1 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/8 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
5.9%
1/17 • Number of events 1 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
8.3%
1/12 • Number of events 1 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/12 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/2 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/21 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/20 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
5.3%
1/19 • Number of events 1 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/19 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/10 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
|
Nervous system disorders
Headache
|
0.00%
0/8 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
16.7%
1/6 • Number of events 1 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
33.3%
2/6 • Number of events 2 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/15 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
6.7%
3/45 • Number of events 4 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
22.2%
4/18 • Number of events 4 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
5.9%
1/17 • Number of events 1 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
37.5%
3/8 • Number of events 4 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
23.5%
4/17 • Number of events 4 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/8 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
29.4%
5/17 • Number of events 6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
8.3%
1/12 • Number of events 1 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/12 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
16.7%
1/6 • Number of events 1 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/2 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
4.8%
1/21 • Number of events 1 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
5.0%
1/20 • Number of events 1 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
10.5%
2/19 • Number of events 3 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
5.3%
1/19 • Number of events 1 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/10 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/8 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
6.7%
1/15 • Number of events 2 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/45 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/18 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/17 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/8 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/17 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/8 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/17 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/12 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/12 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/2 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/21 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/20 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/19 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/19 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/10 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/8 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/15 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
2.2%
1/45 • Number of events 1 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/18 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/17 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/8 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
5.9%
1/17 • Number of events 1 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/8 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/17 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/12 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/12 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/2 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/21 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/20 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/19 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/19 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/10 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
|
Nervous system disorders
Tremor
|
0.00%
0/8 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/15 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/45 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/18 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/17 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
12.5%
1/8 • Number of events 1 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/17 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/8 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/17 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/12 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/12 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/2 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/21 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/20 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/19 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/19 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/10 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/8 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/15 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
4.4%
2/45 • Number of events 2 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/18 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/17 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/8 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/17 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/8 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
5.9%
1/17 • Number of events 2 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/12 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/12 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/2 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/21 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/20 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/19 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/19 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/10 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/8 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/15 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/45 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/18 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/17 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/8 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/17 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
12.5%
1/8 • Number of events 1 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/17 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/12 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/12 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/2 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/21 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/20 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/19 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/19 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/10 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/8 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
6.7%
1/15 • Number of events 1 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
2.2%
1/45 • Number of events 1 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/18 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/17 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/8 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/17 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/8 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/17 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/12 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/12 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
16.7%
1/6 • Number of events 1 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/2 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/21 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/20 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/19 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/19 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/10 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/8 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/15 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/45 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/18 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/17 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/8 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/17 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/8 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
5.9%
1/17 • Number of events 1 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
8.3%
1/12 • Number of events 1 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/12 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/2 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/21 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/20 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/19 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/19 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/10 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/8 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/15 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/45 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/18 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/17 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/8 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/17 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/8 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/17 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/12 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/12 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
16.7%
1/6 • Number of events 1 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/2 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/21 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/20 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/19 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/19 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/10 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/8 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/15 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/45 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/18 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/17 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/8 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/17 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/8 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/17 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
8.3%
1/12 • Number of events 1 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/12 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/2 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/21 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/20 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/19 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/19 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/10 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/8 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
16.7%
1/6 • Number of events 1 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/15 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/45 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
5.6%
1/18 • Number of events 1 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/17 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/8 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/17 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/8 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/17 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/12 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/12 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/2 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/21 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/20 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/19 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/19 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/10 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/8 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/15 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/45 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/18 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/17 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/8 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/17 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
12.5%
1/8 • Number of events 1 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/17 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/12 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/12 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/2 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/21 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/20 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/19 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/19 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/10 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
12.5%
1/8 • Number of events 1 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/15 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/45 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/18 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/17 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/8 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/17 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/8 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/17 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/12 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/12 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/2 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/21 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/20 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/19 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/19 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/10 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
|
Vascular disorders
Hot flush
|
0.00%
0/8 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
16.7%
1/6 • Number of events 1 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/15 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/45 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/18 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/17 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/8 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/17 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/8 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/17 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/12 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/12 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/6 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/2 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/21 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/20 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/19 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/19 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
0.00%
0/10 • Baseline through Follow-up (up to Day 42)
All participants who received at least one dose of study drug. Per protocol, AE's were analysed for each treatment dose in parts B and E and for treatment under fasted versus fed conditions in Part C.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Neither Lilly or Supplier shall publish, discuss, or release data emanating from a study without the other party's express written permission which shall not be unreasonably withheld. Nothing herein shall limit supplier's right to respond to legal inquiries.
- Publication restrictions are in place
Restriction type: OTHER