Trial Outcomes & Findings for A Study of LY3323795 in Healthy Participants (NCT NCT02989389)
NCT ID: NCT02989389
Last Updated: 2020-04-20
Results Overview
Data presented are the number of participants who experienced 1 or more SAEs considered by the investigator to be related to study drug administration is reported. SAEs were classified using the Medical Dictionary for Regulatory Activities (MedDRA) 19.1. A summary of non-serious adverse events and all serious adverse events, regardless of causality is located in the Reported Adverse Events section.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
42 participants
Primary outcome timeframe
Baseline to Study Completion (up to Day 43)
Results posted on
2020-04-20
Participant Flow
Part A was a dose-escalation 3-period crossover with 2 alternating cohorts (Cohorts 1 and 2). There was 14 days of washout time between each dose. Part B was a single-dose, 3-cohort (Cohorts 3, 4 and 5) study.
Participant milestones
| Measure |
Part A-Cohort 1 (Sequence 3)
Participants received 0.3 mg, 3 mg, 30 mg LY3323795 and Placebo. Period 1: 0.3 mg LY3323795, Period 2: 3 mg LY3323795, Period 3: Placebo
|
Part A-Cohort 2 (Sequence 1)
Participants received 1 mg, 10 mg, 100 mg of LY3323795 and Placebo. Period 1: 1 mg LY3323795, Period 2: 10 mg LY3323795, Period 3: Placebo
|
Part A-Cohort 2 (Sequence 2)
Participants received 1 mg, 10 mg, 100 mg of LY3323795 and Placebo. Period 1: Placebo, Period 2: 10 mg LY3323795, Period 3: 100 mg LY3323795
|
Part A-Cohort 2 (Sequence 3)
Participants received 1 mg, 10 mg, 100 mg of LY3323795 and Placebo. Period 1: 1 mg LY3323795, Period 2: Placebo, Period 3: 100 mg LY3323795
|
Part B, 6 mg LY3323795
Participants received 6 mg of LY3323795 orally.
|
Part B, 20 mg LY3323795
Participants received 20 mg of LY3323795 orally.
|
Part B, 80 mg LY3323795
Participants received 80 mg of LY3323795 orally.
|
Part B, Placebo
Participants received placebo identical to LY3323795 orally.
|
Part A-Cohort 1 (Sequence 1)
Participants received 0.3 milligrams (mg), 3 mg, 30 mg LY3323795 and Placebo. Period 1: Placebo, Period 2: 3 mg LY3323795, Period 3: 30 mg LY3323795
|
Part A-Cohort 1 (Sequence 2)
Participants received 0.3 mg, 3 mg, 30 mg LY3323795 and Placebo. Period 1: 0.3 mg LY3323795, Period 2: Placebo, Period 3: 30 mg LY3323795
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Period 1
STARTED
|
3
|
3
|
3
|
3
|
6
|
5
|
6
|
6
|
3
|
4
|
|
Period 1
Received at Least 1 Dose of Study Drug
|
3
|
3
|
3
|
3
|
6
|
5
|
6
|
6
|
3
|
4
|
|
Period 1
COMPLETED
|
3
|
3
|
3
|
3
|
6
|
5
|
5
|
6
|
3
|
3
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
|
Period 2
STARTED
|
3
|
3
|
3
|
3
|
0
|
0
|
0
|
0
|
3
|
3
|
|
Period 2
COMPLETED
|
3
|
3
|
3
|
3
|
0
|
0
|
0
|
0
|
3
|
3
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 3
STARTED
|
3
|
3
|
3
|
3
|
0
|
0
|
0
|
0
|
3
|
3
|
|
Period 3
COMPLETED
|
3
|
3
|
3
|
3
|
0
|
0
|
0
|
0
|
3
|
3
|
|
Period 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Part A-Cohort 1 (Sequence 3)
Participants received 0.3 mg, 3 mg, 30 mg LY3323795 and Placebo. Period 1: 0.3 mg LY3323795, Period 2: 3 mg LY3323795, Period 3: Placebo
|
Part A-Cohort 2 (Sequence 1)
Participants received 1 mg, 10 mg, 100 mg of LY3323795 and Placebo. Period 1: 1 mg LY3323795, Period 2: 10 mg LY3323795, Period 3: Placebo
|
Part A-Cohort 2 (Sequence 2)
Participants received 1 mg, 10 mg, 100 mg of LY3323795 and Placebo. Period 1: Placebo, Period 2: 10 mg LY3323795, Period 3: 100 mg LY3323795
|
Part A-Cohort 2 (Sequence 3)
Participants received 1 mg, 10 mg, 100 mg of LY3323795 and Placebo. Period 1: 1 mg LY3323795, Period 2: Placebo, Period 3: 100 mg LY3323795
|
Part B, 6 mg LY3323795
Participants received 6 mg of LY3323795 orally.
|
Part B, 20 mg LY3323795
Participants received 20 mg of LY3323795 orally.
|
Part B, 80 mg LY3323795
Participants received 80 mg of LY3323795 orally.
|
Part B, Placebo
Participants received placebo identical to LY3323795 orally.
|
Part A-Cohort 1 (Sequence 1)
Participants received 0.3 milligrams (mg), 3 mg, 30 mg LY3323795 and Placebo. Period 1: Placebo, Period 2: 3 mg LY3323795, Period 3: 30 mg LY3323795
|
Part A-Cohort 1 (Sequence 2)
Participants received 0.3 mg, 3 mg, 30 mg LY3323795 and Placebo. Period 1: 0.3 mg LY3323795, Period 2: Placebo, Period 3: 30 mg LY3323795
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Period 1
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Period 1
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
A Study of LY3323795 in Healthy Participants
Baseline characteristics by cohort
| Measure |
Part A-Cohort 1 (Sequence 1)
n=3 Participants
Participants received 0.3 milligrams (mg), 3 mg, 30 mg LY3323795 and Placebo. Period 1: Placebo, Period 2: 3 mg LY3323795, Period 3: 30 mg LY3323795.
|
Part A-Cohort 1 (Sequence 2)
n=4 Participants
Participants received 0.3 mg, 3 mg, 30 mg LY3323795 and Placebo. Period 1: 0.3 mg LY3323795, Period 2: Placebo, Period 3: 30 mg LY3323795.
|
Part A-Cohort 1 (Sequence 3)
n=3 Participants
Participants received 0.3 mg, 3 mg, 30 mg LY3323795 and Placebo. Period 1: 0.3 mg LY3323795, Period 2: 3 mg LY3323795, Period 3: Placebo.
|
Part A-Cohort 2 (Sequence 1)
n=3 Participants
Participants received 1 mg, 10 mg, 100 mg of LY3323795 and Placebo. Period 1: 1 mg LY3323795, Period 2: 10 mg LY3323795, Period 3: Placebo.
|
Part A-Cohort 2 (Sequence 2)
n=3 Participants
Participants received 1 mg, 10 mg, 100 mg of LY3323795 and Placebo. Period 1: Placebo, Period 2: 10 mg LY3323795, Period 3: 100 mg LY3323795.
|
Part A-Cohort 2 (Sequence 3)
n=3 Participants
Participants received 1 mg, 10 mg, 100 mg of LY3323795 and Placebo. Period 1: 1 mg LY3323795, Period 2: Placebo, Period 3: 100 mg LY3323795.
|
Part B, 6 mg LY3323795
n=6 Participants
Participants received 6 mg of LY3323795 orally.
|
Part B, 20 mg LY3323795
n=5 Participants
Participants received 20 mg of LY3323795 orally.
|
Part B, 80 mg LY3323795
n=6 Participants
Participants received 80 mg of LY3323795 orally.
|
Part B, Placebo
n=6 Participants
Participants received placebo identical to LY3323795 orally.
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
6 Participants
n=3 Participants
|
4 Participants
n=6 Participants
|
6 Participants
n=114 Participants
|
6 Participants
|
41 Participants
n=19 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
1 Participants
n=19 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
3 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
1 Participants
n=114 Participants
|
2 Participants
|
11 Participants
n=19 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
3 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
5 Participants
n=114 Participants
|
4 Participants
|
31 Participants
n=19 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
9 Participants
n=19 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
5 Participants
n=3 Participants
|
5 Participants
n=6 Participants
|
6 Participants
n=114 Participants
|
5 Participants
|
32 Participants
n=19 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
1 Participants
|
1 Participants
n=19 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=114 Participants
|
1 Participants
|
3 Participants
n=19 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=114 Participants
|
1 Participants
|
10 Participants
n=19 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
5 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
3 Participants
n=114 Participants
|
3 Participants
|
26 Participants
n=19 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
1 Participants
|
3 Participants
n=19 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
|
Region of Enrollment
United States
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
6 Participants
n=3 Participants
|
5 Participants
n=6 Participants
|
6 Participants
n=114 Participants
|
6 Participants
|
42 Participants
n=19 Participants
|
PRIMARY outcome
Timeframe: Baseline to Study Completion (up to Day 43)Population: All randomized participants who received study drug.
Data presented are the number of participants who experienced 1 or more SAEs considered by the investigator to be related to study drug administration is reported. SAEs were classified using the Medical Dictionary for Regulatory Activities (MedDRA) 19.1. A summary of non-serious adverse events and all serious adverse events, regardless of causality is located in the Reported Adverse Events section.
Outcome measures
| Measure |
Part A, Cohort 1, Placebo
n=9 Participants
Participants received placebo identical to LY3323795 orally.
|
Part A, Cohort 1, 0.3 mg LY3323795
n=6 Participants
Participants received 0.3 mg of LY3323795 orally.
|
Part A, Cohort 1, 3 mg LY3323795
n=6 Participants
Participants received 3 mg of LY3323795 orally.
|
Part A, Cohort 1, 30 mg LY3323795
n=6 Participants
Participants received 30 mg of LY3323795 orally.
|
Part A, Cohort 2, Placebo
n=9 Participants
Participants received placebo identical to LY3323795 orally.
|
Part A, Cohort 2, 1 mg LY3323795
n=6 Participants
Participants received 1 mg of LY3323795 orally.
|
Part A, Cohort 2, 10 mg LY3323795
n=6 Participants
Participants received 10 mg of LY3323795 orally.
|
Part A, Cohort 2, 100 mg LY3323795
n=6 Participants
Participants received 100 mg of LY3323795 orally.
|
Part B, Placebo
n=6 Participants
Participants received placebo identical to LY3323795 orally.
|
Part B, 6 mg LY3323795
n=6 Participants
Participants received 6 mg of LY3323795 orally.
|
Part B, 20 mg LY3323795
n=5 Participants
Participants received 20 mg of LY3323795 orally.
|
Part B, 80 mg LY3323795
n=6 Participants
Participants received 80 mg of LY3323795 orally.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
|
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: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72,96,120,144 hours, post dosePopulation: All randomized participants who received at least 1 dose of study drug and had evaluable PK data.
Pharmacokinetics (PK): Maximum observed drug concentration (Cmax) of LY3323795 in plasma.
Outcome measures
| Measure |
Part A, Cohort 1, Placebo
n=6 Participants
Participants received placebo identical to LY3323795 orally.
|
Part A, Cohort 1, 0.3 mg LY3323795
n=6 Participants
Participants received 0.3 mg of LY3323795 orally.
|
Part A, Cohort 1, 3 mg LY3323795
n=6 Participants
Participants received 3 mg of LY3323795 orally.
|
Part A, Cohort 1, 30 mg LY3323795
n=6 Participants
Participants received 30 mg of LY3323795 orally.
|
Part A, Cohort 2, Placebo
n=6 Participants
Participants received placebo identical to LY3323795 orally.
|
Part A, Cohort 2, 1 mg LY3323795
n=6 Participants
Participants received 1 mg of LY3323795 orally.
|
Part A, Cohort 2, 10 mg LY3323795
n=6 Participants
Participants received 10 mg of LY3323795 orally.
|
Part A, Cohort 2, 100 mg LY3323795
n=5 Participants
Participants received 100 mg of LY3323795 orally.
|
Part B, Placebo
n=6 Participants
Participants received placebo identical to LY3323795 orally.
|
Part B, 6 mg LY3323795
Participants received 6 mg of LY3323795 orally.
|
Part B, 20 mg LY3323795
Participants received 20 mg of LY3323795 orally.
|
Part B, 80 mg LY3323795
Participants received 80 mg of LY3323795 orally.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3323795 in Plasma
|
0.503 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 32
|
1.77 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 29
|
4.79 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 24
|
15.7 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 25
|
34.6 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 35
|
89.1 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 44
|
10.4 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 45
|
27.2 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 26
|
88.1 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 34
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: -4, -2, 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36 hours, post dosePopulation: All randomized participants from Part B group, who received at least 1 dose of study drug and had evaluable PK data.
Part B Pharmacokinetics (PK): Maximum observed drug concentration (Cmax) of LY3323795 in cerebrospinal fluid (CSF).
Outcome measures
| Measure |
Part A, Cohort 1, Placebo
n=6 Participants
Participants received placebo identical to LY3323795 orally.
|
Part A, Cohort 1, 0.3 mg LY3323795
n=5 Participants
Participants received 0.3 mg of LY3323795 orally.
|
Part A, Cohort 1, 3 mg LY3323795
n=6 Participants
Participants received 3 mg of LY3323795 orally.
|
Part A, Cohort 1, 30 mg LY3323795
Participants received 30 mg of LY3323795 orally.
|
Part A, Cohort 2, Placebo
Participants received placebo identical to LY3323795 orally.
|
Part A, Cohort 2, 1 mg LY3323795
Participants received 1 mg of LY3323795 orally.
|
Part A, Cohort 2, 10 mg LY3323795
Participants received 10 mg of LY3323795 orally.
|
Part A, Cohort 2, 100 mg LY3323795
Participants received 100 mg of LY3323795 orally.
|
Part B, Placebo
Participants received placebo identical to LY3323795 orally.
|
Part B, 6 mg LY3323795
Participants received 6 mg of LY3323795 orally.
|
Part B, 20 mg LY3323795
Participants received 20 mg of LY3323795 orally.
|
Part B, 80 mg LY3323795
Participants received 80 mg of LY3323795 orally.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part B Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3323795 in Cerebrospinal Fluid (CSF)
|
0.293 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 31
|
0.788 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 11
|
2.86 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 34
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72,96,120,144 hours, post dosePopulation: All randomized participants who received at least 1 dose of study drug and had evaluable PK data.
Pharmacokinetics (PK): Area under the concentration time curve from time zero to tlast (AUC\[0-tlast\]) of LY3323795 in plasma.
Outcome measures
| Measure |
Part A, Cohort 1, Placebo
n=6 Participants
Participants received placebo identical to LY3323795 orally.
|
Part A, Cohort 1, 0.3 mg LY3323795
n=6 Participants
Participants received 0.3 mg of LY3323795 orally.
|
Part A, Cohort 1, 3 mg LY3323795
n=6 Participants
Participants received 3 mg of LY3323795 orally.
|
Part A, Cohort 1, 30 mg LY3323795
n=6 Participants
Participants received 30 mg of LY3323795 orally.
|
Part A, Cohort 2, Placebo
n=6 Participants
Participants received placebo identical to LY3323795 orally.
|
Part A, Cohort 2, 1 mg LY3323795
n=6 Participants
Participants received 1 mg of LY3323795 orally.
|
Part A, Cohort 2, 10 mg LY3323795
n=6 Participants
Participants received 10 mg of LY3323795 orally.
|
Part A, Cohort 2, 100 mg LY3323795
n=7 Participants
Participants received 100 mg of LY3323795 orally.
|
Part B, Placebo
n=6 Participants
Participants received placebo identical to LY3323795 orally.
|
Part B, 6 mg LY3323795
Participants received 6 mg of LY3323795 orally.
|
Part B, 20 mg LY3323795
Participants received 20 mg of LY3323795 orally.
|
Part B, 80 mg LY3323795
Participants received 80 mg of LY3323795 orally.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics (PK): Area Under the Concentration Time Curve From Time Zero to Tlast (AUC[0-tlast]) of LY3323795 in Plasma
|
5.67 nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 69
|
25.2 nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 28
|
73.4 nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 31
|
274 nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 14
|
663 nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 35
|
2370 nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 29
|
156 nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 17
|
441 nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 24
|
1950 nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 49
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: -4, -2, 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36 hours, post dosePopulation: All randomized participants from Part B group, who received at least 1 dose of study drug and had evaluable PK data.
Part B Pharmacokinetics (PK): Area under the concentration time curve from time zero to tlast (AUC\[0-tlast\]) of LY3323795 in cerebrospinal fluid (CSF).
Outcome measures
| Measure |
Part A, Cohort 1, Placebo
n=6 Participants
Participants received placebo identical to LY3323795 orally.
|
Part A, Cohort 1, 0.3 mg LY3323795
n=5 Participants
Participants received 0.3 mg of LY3323795 orally.
|
Part A, Cohort 1, 3 mg LY3323795
n=6 Participants
Participants received 3 mg of LY3323795 orally.
|
Part A, Cohort 1, 30 mg LY3323795
Participants received 30 mg of LY3323795 orally.
|
Part A, Cohort 2, Placebo
Participants received placebo identical to LY3323795 orally.
|
Part A, Cohort 2, 1 mg LY3323795
Participants received 1 mg of LY3323795 orally.
|
Part A, Cohort 2, 10 mg LY3323795
Participants received 10 mg of LY3323795 orally.
|
Part A, Cohort 2, 100 mg LY3323795
Participants received 100 mg of LY3323795 orally.
|
Part B, Placebo
Participants received placebo identical to LY3323795 orally.
|
Part B, 6 mg LY3323795
Participants received 6 mg of LY3323795 orally.
|
Part B, 20 mg LY3323795
Participants received 20 mg of LY3323795 orally.
|
Part B, 80 mg LY3323795
Participants received 80 mg of LY3323795 orally.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part B Pharmacokinetics (PK): Area Under the Concentration Time Curve From Time Zero to Tlast (AUC[0-tlast]) of LY3323795 in Cerebrospinal Fluid (CSF)
|
5.46 ng*h/mL
Geometric Coefficient of Variation 24
|
13.7 ng*h/mL
Geometric Coefficient of Variation 16
|
55.1 ng*h/mL
Geometric Coefficient of Variation 48
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline through 144 hoursPopulation: All randomized participants who received at least 1 dose of study drug and have baseline and at least one post-baseline plasma Aβ1-40 or Aβ1-42 data.
Amyloid beta is a peptide fragment of the amyloid precursor protein, plasma concentrations of Aβ1-40 and Aβ1-42 were determined using validated immunoassay methods.
Outcome measures
| Measure |
Part A, Cohort 1, Placebo
n=6 Participants
Participants received placebo identical to LY3323795 orally.
|
Part A, Cohort 1, 0.3 mg LY3323795
n=6 Participants
Participants received 0.3 mg of LY3323795 orally.
|
Part A, Cohort 1, 3 mg LY3323795
n=6 Participants
Participants received 3 mg of LY3323795 orally.
|
Part A, Cohort 1, 30 mg LY3323795
n=6 Participants
Participants received 30 mg of LY3323795 orally.
|
Part A, Cohort 2, Placebo
n=6 Participants
Participants received placebo identical to LY3323795 orally.
|
Part A, Cohort 2, 1 mg LY3323795
n=6 Participants
Participants received 1 mg of LY3323795 orally.
|
Part A, Cohort 2, 10 mg LY3323795
n=6 Participants
Participants received 10 mg of LY3323795 orally.
|
Part A, Cohort 2, 100 mg LY3323795
n=5 Participants
Participants received 100 mg of LY3323795 orally.
|
Part B, Placebo
n=5 Participants
Participants received placebo identical to LY3323795 orally.
|
Part B, 6 mg LY3323795
n=24 Participants
Participants received 6 mg of LY3323795 orally.
|
Part B, 20 mg LY3323795
Participants received 20 mg of LY3323795 orally.
|
Part B, 80 mg LY3323795
Participants received 80 mg of LY3323795 orally.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacodynamics (PD): Change From Baseline in Plasma Amyloid Beta (Aβ)₁-₄₀ and Aβ₁-₄₂
Aβ1-40
|
-39 Picogram per milliliter (pg/mL)
Standard Deviation 8
|
-52 Picogram per milliliter (pg/mL)
Standard Deviation 6
|
-71 Picogram per milliliter (pg/mL)
Standard Deviation 7
|
-76 Picogram per milliliter (pg/mL)
Standard Deviation 4
|
-76 Picogram per milliliter (pg/mL)
Standard Deviation 18
|
-89 Picogram per milliliter (pg/mL)
Standard Deviation 2
|
-79 Picogram per milliliter (pg/mL)
Standard Deviation 7
|
-81 Picogram per milliliter (pg/mL)
Standard Deviation 5
|
-89 Picogram per milliliter (pg/mL)
Standard Deviation 1
|
-23 Picogram per milliliter (pg/mL)
Standard Deviation 11
|
—
|
—
|
|
Pharmacodynamics (PD): Change From Baseline in Plasma Amyloid Beta (Aβ)₁-₄₀ and Aβ₁-₄₂
Aβ1-42
|
-22 Picogram per milliliter (pg/mL)
Standard Deviation 7
|
-33 Picogram per milliliter (pg/mL)
Standard Deviation 6
|
-49 Picogram per milliliter (pg/mL)
Standard Deviation 5
|
-60 Picogram per milliliter (pg/mL)
Standard Deviation 5
|
-63 Picogram per milliliter (pg/mL)
Standard Deviation 8
|
-75 Picogram per milliliter (pg/mL)
Standard Deviation 3
|
-54 Picogram per milliliter (pg/mL)
Standard Deviation 11
|
-58 Picogram per milliliter (pg/mL)
Standard Deviation 6
|
-64 Picogram per milliliter (pg/mL)
Standard Deviation 9
|
-12 Picogram per milliliter (pg/mL)
Standard Deviation 6
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline through 36 hoursPopulation: All randomized participants from Part B group, who received at least 1 dose of study drug and have baseline and at least one post-baseline CSF Aβ1-40 or Aβ1-42 data.
Amyloid beta is a peptide fragment of the amyloid precursor protein, CSF concentrations of Aβ1-40, Aβ1-42 were determined using validated immunoassay methods.
Outcome measures
| Measure |
Part A, Cohort 1, Placebo
n=6 Participants
Participants received placebo identical to LY3323795 orally.
|
Part A, Cohort 1, 0.3 mg LY3323795
n=5 Participants
Participants received 0.3 mg of LY3323795 orally.
|
Part A, Cohort 1, 3 mg LY3323795
n=4 Participants
Participants received 3 mg of LY3323795 orally.
|
Part A, Cohort 1, 30 mg LY3323795
n=6 Participants
Participants received 30 mg of LY3323795 orally.
|
Part A, Cohort 2, Placebo
Participants received placebo identical to LY3323795 orally.
|
Part A, Cohort 2, 1 mg LY3323795
Participants received 1 mg of LY3323795 orally.
|
Part A, Cohort 2, 10 mg LY3323795
Participants received 10 mg of LY3323795 orally.
|
Part A, Cohort 2, 100 mg LY3323795
Participants received 100 mg of LY3323795 orally.
|
Part B, Placebo
Participants received placebo identical to LY3323795 orally.
|
Part B, 6 mg LY3323795
Participants received 6 mg of LY3323795 orally.
|
Part B, 20 mg LY3323795
Participants received 20 mg of LY3323795 orally.
|
Part B, 80 mg LY3323795
Participants received 80 mg of LY3323795 orally.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part B Pharmacodynamics (PD): Change From Baseline in Cerebrospinal Fluid (CSF) Amyloid Beta (Aβ)₁-₄₀ and Aβ₁-₄₂
Aβ 1-40
|
-51 Picogram per milliliter (pg/mL)
Standard Deviation 21
|
-69 Picogram per milliliter (pg/mL)
Standard Deviation 6
|
-88 Picogram per milliliter (pg/mL)
Standard Deviation 4
|
-12 Picogram per milliliter (pg/mL)
Standard Deviation 11
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B Pharmacodynamics (PD): Change From Baseline in Cerebrospinal Fluid (CSF) Amyloid Beta (Aβ)₁-₄₀ and Aβ₁-₄₂
Aβ 1-42
|
-37 Picogram per milliliter (pg/mL)
Standard Deviation 23
|
-71 Picogram per milliliter (pg/mL)
Standard Deviation 10
|
-81 Picogram per milliliter (pg/mL)
Standard Deviation 7
|
-17 Picogram per milliliter (pg/mL)
Standard Deviation 23
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Part A, Cohort 1, Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part A, Cohort 1, 0.3 mg LY3323795
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part A, Cohort 1, 3 mg LY3323795
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part A, Cohort 1, 30 mg LY3323795
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part A, Cohort 2, Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part A, Cohort 2, 1 mg LY3323795
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part A, Cohort 2, 10 mg LY3323795
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part A, Cohort 2, 100 mg LY3323795
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part B, 6 mg LY3323795
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Part B, 20 mg LY3323795
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part B, 80 mg LY3323795
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Part B, Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Part A, Cohort 1, Placebo
n=9 participants at risk
Participants received placebo identical to LY3323795 orally.
|
Part A, Cohort 1, 0.3 mg LY3323795
n=6 participants at risk
Participants received 0.3 mg of LY3323795 orally.
|
Part A, Cohort 1, 3 mg LY3323795
n=6 participants at risk
Participants received 3 mg of LY3323795 orally.
|
Part A, Cohort 1, 30 mg LY3323795
n=6 participants at risk
Participants received 30 mg of LY3323795 orally.
|
Part A, Cohort 2, Placebo
n=9 participants at risk
Participants received placebo identical to LY3323795 orally.
|
Part A, Cohort 2, 1 mg LY3323795
n=6 participants at risk
Participants received 1 mg of LY3323795 orally.
|
Part A, Cohort 2, 10 mg LY3323795
n=6 participants at risk
Participants received 10 mg of LY3323795 orally.
|
Part A, Cohort 2, 100 mg LY3323795
n=6 participants at risk
Participants received 100 mg of LY3323795 orally.
|
Part B, 6 mg LY3323795
n=6 participants at risk
Participants received 6 mg of LY3323795 orally.
|
Part B, 20 mg LY3323795
n=5 participants at risk
Participants received 20 mg of LY3323795 orally.
|
Part B, 80 mg LY3323795
n=6 participants at risk
Participants received 80 mg of LY3323795 orally.
|
Part B, Placebo
n=6 participants at risk
Participants received placebo identical to LY3323795 orally.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Eye disorders
Vision blurred
|
0.00%
0/9 • Up to 43 days
All enrolled participants who received study drug.
|
16.7%
1/6 • Number of events 1 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/9 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/5 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/9 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/9 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/5 • Up to 43 days
All enrolled participants who received study drug.
|
16.7%
1/6 • Number of events 1 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/9 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/9 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/5 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
16.7%
1/6 • Number of events 1 • Up to 43 days
All enrolled participants who received study drug.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/9 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/9 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
16.7%
1/6 • Number of events 1 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/5 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
|
Gastrointestinal disorders
Diarrhoea haemorrhagic
|
0.00%
0/9 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/9 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/5 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
16.7%
1/6 • Number of events 1 • Up to 43 days
All enrolled participants who received study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/9 • Up to 43 days
All enrolled participants who received study drug.
|
16.7%
1/6 • Number of events 1 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/9 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
16.7%
1/6 • Number of events 1 • Up to 43 days
All enrolled participants who received study drug.
|
16.7%
1/6 • Number of events 1 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/5 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/9 • Up to 43 days
All enrolled participants who received study drug.
|
16.7%
1/6 • Number of events 1 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/9 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
16.7%
1/6 • Number of events 1 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/5 • Up to 43 days
All enrolled participants who received study drug.
|
16.7%
1/6 • Number of events 1 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
|
General disorders
Catheter site pain
|
0.00%
0/9 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/9 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
20.0%
1/5 • Number of events 1 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
|
General disorders
Fatigue
|
0.00%
0/9 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/9 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/5 • Up to 43 days
All enrolled participants who received study drug.
|
16.7%
1/6 • Number of events 1 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
|
General disorders
Vessel puncture site bruise
|
0.00%
0/9 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/9 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
20.0%
1/5 • Number of events 1 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/9 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
11.1%
1/9 • Number of events 1 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/5 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/9 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/9 • Up to 43 days
All enrolled participants who received study drug.
|
16.7%
1/6 • Number of events 1 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/5 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
|
Injury, poisoning and procedural complications
Post lumbar puncture syndrome
|
0.00%
0/9 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/9 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
33.3%
2/6 • Number of events 2 • Up to 43 days
All enrolled participants who received study drug.
|
20.0%
1/5 • Number of events 1 • Up to 43 days
All enrolled participants who received study drug.
|
50.0%
3/6 • Number of events 3 • Up to 43 days
All enrolled participants who received study drug.
|
33.3%
2/6 • Number of events 2 • Up to 43 days
All enrolled participants who received study drug.
|
|
Injury, poisoning and procedural complications
Procedural complication
|
0.00%
0/9 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/9 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/5 • Up to 43 days
All enrolled participants who received study drug.
|
16.7%
1/6 • Number of events 2 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
|
Injury, poisoning and procedural complications
Procedural headache
|
0.00%
0/9 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/9 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
16.7%
1/6 • Number of events 1 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/5 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
0.00%
0/9 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/9 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/5 • Up to 43 days
All enrolled participants who received study drug.
|
16.7%
1/6 • Number of events 1 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/9 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/9 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
16.7%
1/6 • Number of events 1 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/5 • Up to 43 days
All enrolled participants who received study drug.
|
33.3%
2/6 • Number of events 4 • Up to 43 days
All enrolled participants who received study drug.
|
16.7%
1/6 • Number of events 2 • Up to 43 days
All enrolled participants who received study drug.
|
|
Injury, poisoning and procedural complications
Procedural vomiting
|
0.00%
0/9 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/9 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/5 • Up to 43 days
All enrolled participants who received study drug.
|
16.7%
1/6 • Number of events 1 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/9 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/9 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
16.7%
1/6 • Number of events 1 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/5 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/9 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/9 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
16.7%
1/6 • Number of events 1 • Up to 43 days
All enrolled participants who received study drug.
|
16.7%
1/6 • Number of events 1 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/5 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/9 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/9 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
16.7%
1/6 • Number of events 1 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/5 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/9 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/9 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
16.7%
1/6 • Number of events 1 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/5 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/9 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/9 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
16.7%
1/6 • Number of events 1 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/5 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
|
Nervous system disorders
Headache
|
0.00%
0/9 • Up to 43 days
All enrolled participants who received study drug.
|
16.7%
1/6 • Number of events 1 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/9 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
16.7%
1/6 • Number of events 1 • Up to 43 days
All enrolled participants who received study drug.
|
16.7%
1/6 • Number of events 1 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/5 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/9 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/9 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/5 • Up to 43 days
All enrolled participants who received study drug.
|
16.7%
1/6 • Number of events 1 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/9 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/9 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/5 • Up to 43 days
All enrolled participants who received study drug.
|
16.7%
1/6 • Number of events 1 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/9 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/9 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
16.7%
1/6 • Number of events 1 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/5 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
0.00%
0/6 • Up to 43 days
All enrolled participants who received study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60