Trial Outcomes & Findings for A Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD9977 After Single Ascending Doses to Healthy Males (NCT NCT02484729)
NCT ID: NCT02484729
Last Updated: 2017-04-28
Results Overview
To assess the safety and tolerability of single ascending doses of AZD9977
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
196 participants
Primary outcome timeframe
For up to 45 days, i.e. from Screening to Follow-up
Results posted on
2017-04-28
Participant Flow
This study was conducted at PAREXEL International, Early Phase Clinical Unit London, United Kingdom.
In this study, 196 subjects were screened out of which 70 subjects were randomized. The study was conducted in two parts (Parts A and B). Part A-eight cohorts of 8 subjects, randomized in 6:2 (AZD9977: placebo) and Part B -1 cohort of 8 subjects who received a single dose of AZD9977, on 2 occasions separated by washout period of 7 days.
Participant milestones
| Measure |
Part A- Placebo
Subjects received matching placebo under fasted conditions
|
Part A - 5 mg AZD9977
Subjects received 5 mg AZD9977, oral suspension under fasted conditions
|
Part A - 25 mg AZD9977
Subjects received 25 mg AZD9977, oral suspension under fasted conditions
|
Part A - 100 mg AZD9977
Subjects received 100 mg AZD9977, oral suspension under fasted conditions
|
Part A - 200 mg AZD9977
Subjects received 200 mg AZD9977, oral suspension under fasted conditions
|
Part A - 400 mg AZD9977
Subjects received 400 mg AZD9977, oral suspension under fasted conditions
|
Part A - 800 mg AZD9977
Subjects received 800 mg AZD9977, oral suspension under fasted conditions
|
Part A - 800 mg AZD9977 (Split Doses)
Subjects received 800 mg AZD9977 (split doses), oral suspension under fasted conditions
|
Part A - 1200 mg AZD9977 (Split Doses)
Subjects received 1200 mg AZD9977 (split doses), oral suspension under fasted conditions
|
Part B
Subjects received a single dose of AZD9977, under fasted conditions, on two occasions (40 mg AZD9977, IntelliCap device and 40 mg AZD9977, oral solution) separated by a washout period of at least 7 days
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
16
|
6
|
6
|
6
|
5
|
6
|
5
|
6
|
6
|
8
|
|
Overall Study
COMPLETED
|
16
|
6
|
6
|
6
|
5
|
6
|
5
|
6
|
6
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Part A- Placebo
Subjects received matching placebo under fasted conditions
|
Part A - 5 mg AZD9977
Subjects received 5 mg AZD9977, oral suspension under fasted conditions
|
Part A - 25 mg AZD9977
Subjects received 25 mg AZD9977, oral suspension under fasted conditions
|
Part A - 100 mg AZD9977
Subjects received 100 mg AZD9977, oral suspension under fasted conditions
|
Part A - 200 mg AZD9977
Subjects received 200 mg AZD9977, oral suspension under fasted conditions
|
Part A - 400 mg AZD9977
Subjects received 400 mg AZD9977, oral suspension under fasted conditions
|
Part A - 800 mg AZD9977
Subjects received 800 mg AZD9977, oral suspension under fasted conditions
|
Part A - 800 mg AZD9977 (Split Doses)
Subjects received 800 mg AZD9977 (split doses), oral suspension under fasted conditions
|
Part A - 1200 mg AZD9977 (Split Doses)
Subjects received 1200 mg AZD9977 (split doses), oral suspension under fasted conditions
|
Part B
Subjects received a single dose of AZD9977, under fasted conditions, on two occasions (40 mg AZD9977, IntelliCap device and 40 mg AZD9977, oral solution) separated by a washout period of at least 7 days
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Failure of IntelliCap Error
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD9977 After Single Ascending Doses to Healthy Males
Baseline characteristics by cohort
| Measure |
Part A- Placebo
n=16 Participants
Subjects received matching placebo under fasted conditions
|
Part A - 5 mg AZD9977
n=6 Participants
Subjects received 5 mg AZD9977, oral suspension under fasted conditions
|
Part A - 25 mg AZD9977
n=6 Participants
Subjects received 25 mg AZD9977, oral suspension under fasted conditions
|
Part A - 100 mg AZD9977
n=6 Participants
Subjects received 100 mg AZD9977, oral suspension under fasted conditions
|
Part A - 200 mg AZD9977
n=5 Participants
Subjects received 200 mg AZD9977, oral suspension under fasted conditions
|
Part A - 400 mg AZD9977
n=6 Participants
Subjects received 400 mg AZD9977, oral suspension under fasted conditions
|
Part A - 800 mg AZD9977
n=5 Participants
Subjects received 800 mg AZD9977, oral suspension under fasted conditions
|
Part A - 800 mg AZD9977 (Split Doses)
n=6 Participants
Subjects received 800 mg AZD9977 (split doses), oral suspension under fasted conditions
|
Part A - 1200 mg AZD9977 (Split Doses)
n=6 Participants
Subjects received 1200 mg AZD9977 (split doses), oral suspension under fasted conditions
|
Part B
n=8 Participants
Subjects received a single dose of AZD9977, under fasted conditions, on two occasions (40 mg AZD9977, IntelliCap device and 40 mg AZD9977, oral solution) separated by a washout period of at least 7 days
|
Total
n=70 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
30 Years
STANDARD_DEVIATION 6 • n=99 Participants
|
32 Years
STANDARD_DEVIATION 11 • n=107 Participants
|
30 Years
STANDARD_DEVIATION 9 • n=206 Participants
|
36 Years
STANDARD_DEVIATION 10 • n=7 Participants
|
32 Years
STANDARD_DEVIATION 10 • n=31 Participants
|
33 Years
STANDARD_DEVIATION 9 • n=30 Participants
|
30 Years
STANDARD_DEVIATION 6 • n=3 Participants
|
32 Years
STANDARD_DEVIATION 8 • n=6 Participants
|
38 Years
STANDARD_DEVIATION 11 • n=114 Participants
|
35 Years
STANDARD_DEVIATION 9
|
33 Years
STANDARD_DEVIATION 9 • n=19 Participants
|
|
Sex/Gender, Customized
Male
|
16 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
6 Participants
n=30 Participants
|
5 Participants
n=3 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=114 Participants
|
8 Participants
|
70 Participants
n=19 Participants
|
PRIMARY outcome
Timeframe: For up to 45 days, i.e. from Screening to Follow-upPopulation: All subjects who received at least one dose of IMP and for whom any safety post-dose data were available were included in the safety analysis for the study.
To assess the safety and tolerability of single ascending doses of AZD9977
Outcome measures
| Measure |
Part A- Placebo
n=16 Participants
Subjects received matching placebo under fasted conditions
|
Part A - 5 mg AZD9977
n=6 Participants
Subjects received 5 mg AZD9977, oral suspension under fasted conditions
|
Part A - 25 mg AZD9977
n=6 Participants
Subjects received 25 mg AZD9977, oral suspension under fasted conditions
|
Part A - 100 mg AZD9977
n=6 Participants
Subjects received 100 mg AZD9977, oral suspension under fasted conditions
|
Part A - 200 mg AZD9977
n=5 Participants
Subjects received 200 mg AZD9977, oral suspension under fasted conditions
|
Part A - 400 mg AZD9977
n=6 Participants
Subjects received 400 mg AZD9977, oral suspension under fasted conditions
|
Part A - 800 mg AZD9977
n=5 Participants
Subjects received 800 mg AZD9977, oral suspension under fasted conditions
|
Part A - 800 mg AZD9977 (Split Doses)
n=6 Participants
Subjects received 800 mg AZD9977 (split doses), oral suspension under fasted conditions
|
Part A - 1200 mg AZD9977 (Split Doses)
n=6 Participants
Subjects received 1200 mg AZD9977 (split doses), oral suspension under fasted conditions
|
Part B
n=8 Participants
Subjects received a single dose of AZD9977, under fasted conditions, on two occasions (40 mg AZD9977, IntelliCap device and 40 mg AZD9977, oral solution) separated by a washout period of at least 7 days
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Safety and Tolerability of AZD9977 by Assessing the Percentage of Participants With Adverse Events
|
43.8 percentage of participants
|
16.7 percentage of participants
|
33.3 percentage of participants
|
33.3 percentage of participants
|
20.0 percentage of participants
|
33.3 percentage of participants
|
0 percentage of participants
|
33.3 percentage of participants
|
16.7 percentage of participants
|
37.5 percentage of participants
|
PRIMARY outcome
Timeframe: For up to 45 days, i.e. from Screening to Follow-upPopulation: All subjects who received at least one dose of IMP and for whom any safety post-dose data were available were included in the safety analysis for the study.
To assess the safety and tolerability of single ascending doses of AZD9977
Outcome measures
| Measure |
Part A- Placebo
n=16 Participants
Subjects received matching placebo under fasted conditions
|
Part A - 5 mg AZD9977
n=6 Participants
Subjects received 5 mg AZD9977, oral suspension under fasted conditions
|
Part A - 25 mg AZD9977
n=6 Participants
Subjects received 25 mg AZD9977, oral suspension under fasted conditions
|
Part A - 100 mg AZD9977
n=6 Participants
Subjects received 100 mg AZD9977, oral suspension under fasted conditions
|
Part A - 200 mg AZD9977
n=5 Participants
Subjects received 200 mg AZD9977, oral suspension under fasted conditions
|
Part A - 400 mg AZD9977
n=6 Participants
Subjects received 400 mg AZD9977, oral suspension under fasted conditions
|
Part A - 800 mg AZD9977
n=5 Participants
Subjects received 800 mg AZD9977, oral suspension under fasted conditions
|
Part A - 800 mg AZD9977 (Split Doses)
n=6 Participants
Subjects received 800 mg AZD9977 (split doses), oral suspension under fasted conditions
|
Part A - 1200 mg AZD9977 (Split Doses)
n=6 Participants
Subjects received 1200 mg AZD9977 (split doses), oral suspension under fasted conditions
|
Part B
n=8 Participants
Subjects received a single dose of AZD9977, under fasted conditions, on two occasions (40 mg AZD9977, IntelliCap device and 40 mg AZD9977, oral solution) separated by a washout period of at least 7 days
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Safety and Tolerability of AZD9977 by Assessing Number of Participants With Clinically Significant Pulse Rate
|
0 Number of Participants
|
0 Number of Participants
|
0 Number of Participants
|
0 Number of Participants
|
0 Number of Participants
|
0 Number of Participants
|
0 Number of Participants
|
0 Number of Participants
|
0 Number of Participants
|
0 Number of Participants
|
PRIMARY outcome
Timeframe: For up to 45 days, i.e. from Screening to Follow-upPopulation: All subjects who received at least one dose of IMP and for whom any safety post-dose data were available were included in the safety analysis for the study.
To assess the safety and tolerability of single ascending doses of AZD9977
Outcome measures
| Measure |
Part A- Placebo
n=16 Participants
Subjects received matching placebo under fasted conditions
|
Part A - 5 mg AZD9977
n=6 Participants
Subjects received 5 mg AZD9977, oral suspension under fasted conditions
|
Part A - 25 mg AZD9977
n=6 Participants
Subjects received 25 mg AZD9977, oral suspension under fasted conditions
|
Part A - 100 mg AZD9977
n=6 Participants
Subjects received 100 mg AZD9977, oral suspension under fasted conditions
|
Part A - 200 mg AZD9977
n=5 Participants
Subjects received 200 mg AZD9977, oral suspension under fasted conditions
|
Part A - 400 mg AZD9977
n=6 Participants
Subjects received 400 mg AZD9977, oral suspension under fasted conditions
|
Part A - 800 mg AZD9977
n=5 Participants
Subjects received 800 mg AZD9977, oral suspension under fasted conditions
|
Part A - 800 mg AZD9977 (Split Doses)
n=6 Participants
Subjects received 800 mg AZD9977 (split doses), oral suspension under fasted conditions
|
Part A - 1200 mg AZD9977 (Split Doses)
n=6 Participants
Subjects received 1200 mg AZD9977 (split doses), oral suspension under fasted conditions
|
Part B
n=8 Participants
Subjects received a single dose of AZD9977, under fasted conditions, on two occasions (40 mg AZD9977, IntelliCap device and 40 mg AZD9977, oral solution) separated by a washout period of at least 7 days
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Safety and Tolerability of AZD9977 by Assessing Number of Participants With Clinically Significant Trends in 12-lead Electrocardiograms
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
PRIMARY outcome
Timeframe: For up to 4 days, i.e. on the day before each dosing and for 24 hours after each dosingPopulation: All subjects who received at least one dose of IMP and for whom any safety post-dose data were available were included in the safety analysis for the study.
To assess the safety and tolerability of single ascending doses of AZD9977
Outcome measures
| Measure |
Part A- Placebo
n=16 Participants
Subjects received matching placebo under fasted conditions
|
Part A - 5 mg AZD9977
n=6 Participants
Subjects received 5 mg AZD9977, oral suspension under fasted conditions
|
Part A - 25 mg AZD9977
n=6 Participants
Subjects received 25 mg AZD9977, oral suspension under fasted conditions
|
Part A - 100 mg AZD9977
n=6 Participants
Subjects received 100 mg AZD9977, oral suspension under fasted conditions
|
Part A - 200 mg AZD9977
n=5 Participants
Subjects received 200 mg AZD9977, oral suspension under fasted conditions
|
Part A - 400 mg AZD9977
n=6 Participants
Subjects received 400 mg AZD9977, oral suspension under fasted conditions
|
Part A - 800 mg AZD9977
n=5 Participants
Subjects received 800 mg AZD9977, oral suspension under fasted conditions
|
Part A - 800 mg AZD9977 (Split Doses)
n=6 Participants
Subjects received 800 mg AZD9977 (split doses), oral suspension under fasted conditions
|
Part A - 1200 mg AZD9977 (Split Doses)
n=6 Participants
Subjects received 1200 mg AZD9977 (split doses), oral suspension under fasted conditions
|
Part B
n=8 Participants
Subjects received a single dose of AZD9977, under fasted conditions, on two occasions (40 mg AZD9977, IntelliCap device and 40 mg AZD9977, oral solution) separated by a washout period of at least 7 days
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Safety and Tolerability of AZD9977 by Number of Participants With Clinically Significant Trends in Cardiac Telemetry
|
0 Number of Participants
|
0 Number of Participants
|
0 Number of Participants
|
0 Number of Participants
|
0 Number of Participants
|
0 Number of Participants
|
0 Number of Participants
|
0 Number of Participants
|
0 Number of Participants
|
0 Number of Participants
|
PRIMARY outcome
Timeframe: For up to 45 days, i.e. from Screening to Follow-upPopulation: All subjects who received at least one dose of IMP and for whom any safety post-dose data were available were included in the safety analysis for the study.
To assess the safety and tolerability of single ascending doses of AZD9977
Outcome measures
| Measure |
Part A- Placebo
n=16 Participants
Subjects received matching placebo under fasted conditions
|
Part A - 5 mg AZD9977
n=6 Participants
Subjects received 5 mg AZD9977, oral suspension under fasted conditions
|
Part A - 25 mg AZD9977
n=6 Participants
Subjects received 25 mg AZD9977, oral suspension under fasted conditions
|
Part A - 100 mg AZD9977
n=6 Participants
Subjects received 100 mg AZD9977, oral suspension under fasted conditions
|
Part A - 200 mg AZD9977
n=5 Participants
Subjects received 200 mg AZD9977, oral suspension under fasted conditions
|
Part A - 400 mg AZD9977
n=6 Participants
Subjects received 400 mg AZD9977, oral suspension under fasted conditions
|
Part A - 800 mg AZD9977
n=5 Participants
Subjects received 800 mg AZD9977, oral suspension under fasted conditions
|
Part A - 800 mg AZD9977 (Split Doses)
n=6 Participants
Subjects received 800 mg AZD9977 (split doses), oral suspension under fasted conditions
|
Part A - 1200 mg AZD9977 (Split Doses)
n=6 Participants
Subjects received 1200 mg AZD9977 (split doses), oral suspension under fasted conditions
|
Part B
n=8 Participants
Subjects received a single dose of AZD9977, under fasted conditions, on two occasions (40 mg AZD9977, IntelliCap device and 40 mg AZD9977, oral solution) separated by a washout period of at least 7 days
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Safety and Tolerability of AZD9977 by Assessing the Number of Subjects With Adverse Events
|
7 Number of Participants
|
1 Number of Participants
|
2 Number of Participants
|
2 Number of Participants
|
1 Number of Participants
|
2 Number of Participants
|
0 Number of Participants
|
2 Number of Participants
|
1 Number of Participants
|
3 Number of Participants
|
PRIMARY outcome
Timeframe: For up to 45 days, i.e. from Screening to Follow-upPopulation: All subjects who received at least one dose of IMP and for whom any safety post-dose data were available were included in the safety analysis for the study.
To assess the safety and tolerability of single ascending doses of AZD9977
Outcome measures
| Measure |
Part A- Placebo
n=16 Participants
Subjects received matching placebo under fasted conditions
|
Part A - 5 mg AZD9977
n=6 Participants
Subjects received 5 mg AZD9977, oral suspension under fasted conditions
|
Part A - 25 mg AZD9977
n=6 Participants
Subjects received 25 mg AZD9977, oral suspension under fasted conditions
|
Part A - 100 mg AZD9977
n=6 Participants
Subjects received 100 mg AZD9977, oral suspension under fasted conditions
|
Part A - 200 mg AZD9977
n=5 Participants
Subjects received 200 mg AZD9977, oral suspension under fasted conditions
|
Part A - 400 mg AZD9977
n=6 Participants
Subjects received 400 mg AZD9977, oral suspension under fasted conditions
|
Part A - 800 mg AZD9977
n=5 Participants
Subjects received 800 mg AZD9977, oral suspension under fasted conditions
|
Part A - 800 mg AZD9977 (Split Doses)
n=6 Participants
Subjects received 800 mg AZD9977 (split doses), oral suspension under fasted conditions
|
Part A - 1200 mg AZD9977 (Split Doses)
n=6 Participants
Subjects received 1200 mg AZD9977 (split doses), oral suspension under fasted conditions
|
Part B
n=8 Participants
Subjects received a single dose of AZD9977, under fasted conditions, on two occasions (40 mg AZD9977, IntelliCap device and 40 mg AZD9977, oral solution) separated by a washout period of at least 7 days
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Safety and Tolerability of AZD9977 by Assessing Number of Participants With Clinically Significant Changes in Blood Pressure
|
0 Number of Participants
|
0 Number of Participants
|
0 Number of Participants
|
0 Number of Participants
|
0 Number of Participants
|
0 Number of Participants
|
0 Number of Participants
|
0 Number of Participants
|
0 Number of Participants
|
0 Number of Participants
|
PRIMARY outcome
Timeframe: For up to 45 days, i.e. from Screening to Follow-upPopulation: All subjects who received at least one dose of IMP and for whom any safety post-dose data were available were included in the safety analysis for the study.
To assess the safety and tolerability of single ascending doses of AZD9977
Outcome measures
| Measure |
Part A- Placebo
n=16 Participants
Subjects received matching placebo under fasted conditions
|
Part A - 5 mg AZD9977
n=6 Participants
Subjects received 5 mg AZD9977, oral suspension under fasted conditions
|
Part A - 25 mg AZD9977
n=6 Participants
Subjects received 25 mg AZD9977, oral suspension under fasted conditions
|
Part A - 100 mg AZD9977
n=6 Participants
Subjects received 100 mg AZD9977, oral suspension under fasted conditions
|
Part A - 200 mg AZD9977
n=5 Participants
Subjects received 200 mg AZD9977, oral suspension under fasted conditions
|
Part A - 400 mg AZD9977
n=6 Participants
Subjects received 400 mg AZD9977, oral suspension under fasted conditions
|
Part A - 800 mg AZD9977
n=5 Participants
Subjects received 800 mg AZD9977, oral suspension under fasted conditions
|
Part A - 800 mg AZD9977 (Split Doses)
n=6 Participants
Subjects received 800 mg AZD9977 (split doses), oral suspension under fasted conditions
|
Part A - 1200 mg AZD9977 (Split Doses)
n=6 Participants
Subjects received 1200 mg AZD9977 (split doses), oral suspension under fasted conditions
|
Part B
n=8 Participants
Subjects received a single dose of AZD9977, under fasted conditions, on two occasions (40 mg AZD9977, IntelliCap device and 40 mg AZD9977, oral solution) separated by a washout period of at least 7 days
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Safety and Tolerability of AZD9977 by Assessing Number of Participants With Clinically Significant Changes in Hematology
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
PRIMARY outcome
Timeframe: For up to 45 days, i.e. from Screening to Follow-upPopulation: All subjects who received at least one dose of IMP and for whom any safety post-dose data were available were included in the safety analysis for the study.
To assess the safety and tolerability of single ascending doses of AZD9977
Outcome measures
| Measure |
Part A- Placebo
n=16 Participants
Subjects received matching placebo under fasted conditions
|
Part A - 5 mg AZD9977
n=6 Participants
Subjects received 5 mg AZD9977, oral suspension under fasted conditions
|
Part A - 25 mg AZD9977
n=6 Participants
Subjects received 25 mg AZD9977, oral suspension under fasted conditions
|
Part A - 100 mg AZD9977
n=6 Participants
Subjects received 100 mg AZD9977, oral suspension under fasted conditions
|
Part A - 200 mg AZD9977
n=5 Participants
Subjects received 200 mg AZD9977, oral suspension under fasted conditions
|
Part A - 400 mg AZD9977
n=6 Participants
Subjects received 400 mg AZD9977, oral suspension under fasted conditions
|
Part A - 800 mg AZD9977
n=5 Participants
Subjects received 800 mg AZD9977, oral suspension under fasted conditions
|
Part A - 800 mg AZD9977 (Split Doses)
n=6 Participants
Subjects received 800 mg AZD9977 (split doses), oral suspension under fasted conditions
|
Part A - 1200 mg AZD9977 (Split Doses)
n=6 Participants
Subjects received 1200 mg AZD9977 (split doses), oral suspension under fasted conditions
|
Part B
n=8 Participants
Subjects received a single dose of AZD9977, under fasted conditions, on two occasions (40 mg AZD9977, IntelliCap device and 40 mg AZD9977, oral solution) separated by a washout period of at least 7 days
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Safety and Tolerability of AZD9977 by Assessing Number of Participants With Clinically Significant Changes in Clinical Chemistry
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
PRIMARY outcome
Timeframe: For up to 45 days, i.e. from Screening to Follow-upPopulation: All subjects who received at least one dose of IMP and for whom any safety post-dose data were available were included in the safety analysis for the study.
To assess the safety and tolerability of single ascending doses of AZD9977
Outcome measures
| Measure |
Part A- Placebo
n=16 Participants
Subjects received matching placebo under fasted conditions
|
Part A - 5 mg AZD9977
n=6 Participants
Subjects received 5 mg AZD9977, oral suspension under fasted conditions
|
Part A - 25 mg AZD9977
n=6 Participants
Subjects received 25 mg AZD9977, oral suspension under fasted conditions
|
Part A - 100 mg AZD9977
n=6 Participants
Subjects received 100 mg AZD9977, oral suspension under fasted conditions
|
Part A - 200 mg AZD9977
n=5 Participants
Subjects received 200 mg AZD9977, oral suspension under fasted conditions
|
Part A - 400 mg AZD9977
n=6 Participants
Subjects received 400 mg AZD9977, oral suspension under fasted conditions
|
Part A - 800 mg AZD9977
n=5 Participants
Subjects received 800 mg AZD9977, oral suspension under fasted conditions
|
Part A - 800 mg AZD9977 (Split Doses)
n=6 Participants
Subjects received 800 mg AZD9977 (split doses), oral suspension under fasted conditions
|
Part A - 1200 mg AZD9977 (Split Doses)
n=6 Participants
Subjects received 1200 mg AZD9977 (split doses), oral suspension under fasted conditions
|
Part B
n=8 Participants
Subjects received a single dose of AZD9977, under fasted conditions, on two occasions (40 mg AZD9977, IntelliCap device and 40 mg AZD9977, oral solution) separated by a washout period of at least 7 days
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Safety and Tolerability of AZD9977 by Assessing Number of Participants With Clinically Significant Changes in Urinalysis
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
SECONDARY outcome
Timeframe: Pre-dose and post-dose upto 48 hrsPopulation: The PK analysis set for Part A consisted of all subjects in the safety analysis set who received one dose of AZD9977 and had evaluable PK data. The PK analysis set for Part B consisted of all subjects in the safety analysis set who received at least one dose of AZD9977 and had evaluable PK data in at least one period.
To assess plasma pharmacokinetic parameters following single ascending doses of AZD977
Outcome measures
| Measure |
Part A- Placebo
n=6 Participants
Subjects received matching placebo under fasted conditions
|
Part A - 5 mg AZD9977
n=6 Participants
Subjects received 5 mg AZD9977, oral suspension under fasted conditions
|
Part A - 25 mg AZD9977
n=6 Participants
Subjects received 25 mg AZD9977, oral suspension under fasted conditions
|
Part A - 100 mg AZD9977
n=5 Participants
Subjects received 100 mg AZD9977, oral suspension under fasted conditions
|
Part A - 200 mg AZD9977
n=5 Participants
Subjects received 200 mg AZD9977, oral suspension under fasted conditions
|
Part A - 400 mg AZD9977
n=2 Participants
Subjects received 400 mg AZD9977, oral suspension under fasted conditions
|
Part A - 800 mg AZD9977
n=5 Participants
Subjects received 800 mg AZD9977, oral suspension under fasted conditions
|
Part A - 800 mg AZD9977 (Split Doses)
n=4 Participants
Subjects received 800 mg AZD9977 (split doses), oral suspension under fasted conditions
|
Part A - 1200 mg AZD9977 (Split Doses)
n=4 Participants
Subjects received 1200 mg AZD9977 (split doses), oral suspension under fasted conditions
|
Part B
n=7 Participants
Subjects received a single dose of AZD9977, under fasted conditions, on two occasions (40 mg AZD9977, IntelliCap device and 40 mg AZD9977, oral solution) separated by a washout period of at least 7 days
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration Versus Time Curve (AUC) From Zero Extrapolated to Infinity.
|
514.4 h.nmol/L
Geometric Coefficient of Variation 13.4
|
2473 h.nmol/L
Geometric Coefficient of Variation 24.5
|
9576 h.nmol/L
Geometric Coefficient of Variation 51.9
|
23810 h.nmol/L
Geometric Coefficient of Variation 33.7
|
36210 h.nmol/L
Geometric Coefficient of Variation 28.5
|
38060 h.nmol/L
Geometric Coefficient of Variation 37.2
|
98910 h.nmol/L
Geometric Coefficient of Variation 29.7
|
105700 h.nmol/L
Geometric Coefficient of Variation 30.5
|
2256 h.nmol/L
Geometric Coefficient of Variation 32.6
|
3294 h.nmol/L
Geometric Coefficient of Variation 32.9
|
SECONDARY outcome
Timeframe: Pre-dose and post-dose upto 48 hrsPopulation: The PK analysis set for Part A consisted of all subjects in the safety analysis set who received one dose of AZD9977 and had evaluable PK data. The PK analysis set for Part B consisted of all subjects in the safety analysis set who received at least one dose of AZD9977 and had evaluable PK data in at least one period.
To assess plasma pharmacokinetic parameters following single ascending doses of AZD977
Outcome measures
| Measure |
Part A- Placebo
n=6 Participants
Subjects received matching placebo under fasted conditions
|
Part A - 5 mg AZD9977
n=6 Participants
Subjects received 5 mg AZD9977, oral suspension under fasted conditions
|
Part A - 25 mg AZD9977
n=6 Participants
Subjects received 25 mg AZD9977, oral suspension under fasted conditions
|
Part A - 100 mg AZD9977
n=5 Participants
Subjects received 100 mg AZD9977, oral suspension under fasted conditions
|
Part A - 200 mg AZD9977
n=6 Participants
Subjects received 200 mg AZD9977, oral suspension under fasted conditions
|
Part A - 400 mg AZD9977
n=5 Participants
Subjects received 400 mg AZD9977, oral suspension under fasted conditions
|
Part A - 800 mg AZD9977
n=6 Participants
Subjects received 800 mg AZD9977, oral suspension under fasted conditions
|
Part A - 800 mg AZD9977 (Split Doses)
n=6 Participants
Subjects received 800 mg AZD9977 (split doses), oral suspension under fasted conditions
|
Part A - 1200 mg AZD9977 (Split Doses)
n=7 Participants
Subjects received 1200 mg AZD9977 (split doses), oral suspension under fasted conditions
|
Part B
n=6 Participants
Subjects received a single dose of AZD9977, under fasted conditions, on two occasions (40 mg AZD9977, IntelliCap device and 40 mg AZD9977, oral solution) separated by a washout period of at least 7 days
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Analyte concentrationAUC(0-t)
|
482.7 h.nmol/L
Geometric Coefficient of Variation 14.9
|
2429 h.nmol/L
Geometric Coefficient of Variation 24.7
|
9419 h.nmol/L
Geometric Coefficient of Variation 52.2
|
23470 h.nmol/L
Geometric Coefficient of Variation 34.2
|
35650 h.nmol/L
Geometric Coefficient of Variation 26.0
|
34190 h.nmol/L
Geometric Coefficient of Variation 16.1
|
82720 h.nmol/L
Geometric Coefficient of Variation 35.6
|
93750 h.nmol/L
Geometric Coefficient of Variation 37.5
|
1754 h.nmol/L
Geometric Coefficient of Variation 38.1
|
3136 h.nmol/L
Geometric Coefficient of Variation 31.5
|
SECONDARY outcome
Timeframe: Pre-dose and post-dose upto 48 hrsPopulation: The PK analysis set for Part A consisted of all subjects in the safety analysis set who received one dose of AZD9977 and had evaluable PK data. The PK analysis set for Part B consisted of all subjects in the safety analysis set who received at least one dose of AZD9977 and had evaluable PK data in at least one period.
To assess plasma pharmacokinetic parameters following single ascending doses of AZD977
Outcome measures
| Measure |
Part A- Placebo
n=6 Participants
Subjects received matching placebo under fasted conditions
|
Part A - 5 mg AZD9977
n=6 Participants
Subjects received 5 mg AZD9977, oral suspension under fasted conditions
|
Part A - 25 mg AZD9977
n=6 Participants
Subjects received 25 mg AZD9977, oral suspension under fasted conditions
|
Part A - 100 mg AZD9977
n=5 Participants
Subjects received 100 mg AZD9977, oral suspension under fasted conditions
|
Part A - 200 mg AZD9977
n=6 Participants
Subjects received 200 mg AZD9977, oral suspension under fasted conditions
|
Part A - 400 mg AZD9977
n=5 Participants
Subjects received 400 mg AZD9977, oral suspension under fasted conditions
|
Part A - 800 mg AZD9977
n=6 Participants
Subjects received 800 mg AZD9977, oral suspension under fasted conditions
|
Part A - 800 mg AZD9977 (Split Doses)
n=6 Participants
Subjects received 800 mg AZD9977 (split doses), oral suspension under fasted conditions
|
Part A - 1200 mg AZD9977 (Split Doses)
n=7 Participants
Subjects received 1200 mg AZD9977 (split doses), oral suspension under fasted conditions
|
Part B
n=7 Participants
Subjects received a single dose of AZD9977, under fasted conditions, on two occasions (40 mg AZD9977, IntelliCap device and 40 mg AZD9977, oral solution) separated by a washout period of at least 7 days
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Observed Maximum Concentration (Cmax)
|
201.6 nmol/L
Geometric Coefficient of Variation 27.7
|
952.0 nmol/L
Geometric Coefficient of Variation 20.9
|
3367 nmol/L
Geometric Coefficient of Variation 41.3
|
5966 nmol/L
Geometric Coefficient of Variation 40.6
|
7243 nmol/L
Geometric Coefficient of Variation 27.7
|
7149 nmol/L
Geometric Coefficient of Variation 17.2
|
14310 nmol/L
Geometric Coefficient of Variation 29.1
|
16700 nmol/L
Geometric Coefficient of Variation 29.2
|
161.2 nmol/L
Geometric Coefficient of Variation 36.8
|
790.9 nmol/L
Geometric Coefficient of Variation 22.9
|
SECONDARY outcome
Timeframe: Pre-dose and post-dose upto 48 hrsPopulation: The PK analysis set for Part A consisted of all subjects in the safety analysis set who received one dose of AZD9977 and had evaluable PK data. The PK analysis set for Part B consisted of all subjects in the safety analysis set who received at least one dose of AZD9977 and had evaluable PK data in at least one period.
To assess plasma pharmacokinetic parameters following single ascending doses of AZD977
Outcome measures
| Measure |
Part A- Placebo
n=6 Participants
Subjects received matching placebo under fasted conditions
|
Part A - 5 mg AZD9977
n=6 Participants
Subjects received 5 mg AZD9977, oral suspension under fasted conditions
|
Part A - 25 mg AZD9977
n=6 Participants
Subjects received 25 mg AZD9977, oral suspension under fasted conditions
|
Part A - 100 mg AZD9977
n=5 Participants
Subjects received 100 mg AZD9977, oral suspension under fasted conditions
|
Part A - 200 mg AZD9977
n=6 Participants
Subjects received 200 mg AZD9977, oral suspension under fasted conditions
|
Part A - 400 mg AZD9977
n=5 Participants
Subjects received 400 mg AZD9977, oral suspension under fasted conditions
|
Part A - 800 mg AZD9977
n=6 Participants
Subjects received 800 mg AZD9977, oral suspension under fasted conditions
|
Part A - 800 mg AZD9977 (Split Doses)
n=6 Participants
Subjects received 800 mg AZD9977 (split doses), oral suspension under fasted conditions
|
Part A - 1200 mg AZD9977 (Split Doses)
n=7 Participants
Subjects received 1200 mg AZD9977 (split doses), oral suspension under fasted conditions
|
Part B
n=7 Participants
Subjects received a single dose of AZD9977, under fasted conditions, on two occasions (40 mg AZD9977, IntelliCap device and 40 mg AZD9977, oral solution) separated by a washout period of at least 7 days
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Maximum Observed Plasma Concentration (t Max)
|
0.50 Hour (h)
Interval 0.5 to 1.08
|
0.99 Hour (h)
Interval 0.5 to 1.02
|
0.50 Hour (h)
Interval 0.5 to 1.02
|
1.00 Hour (h)
Interval 0.48 to 1.0
|
0.88 Hour (h)
Interval 0.38 to 1.5
|
0.75 Hour (h)
Interval 0.5 to 1.0
|
3.51 Hour (h)
Interval 3.5 to 4.5
|
3.74 Hour (h)
Interval 2.5 to 4.5
|
4.02 Hour (h)
Interval 1.98 to 5.52
|
0.75 Hour (h)
Interval 0.23 to 1.5
|
SECONDARY outcome
Timeframe: Pre-dose and post-dose upto 48 hrsPopulation: The PK analysis set for Part A consisted of all subjects in the safety analysis set who received one dose of AZD9977 and had evaluable PK data. The PK analysis set for Part B consisted of all subjects in the safety analysis set who received at least one dose of AZD9977 and had evaluable PK data in at least one period.
To assess plasma pharmacokinetic parameters following single ascending doses of AZD977
Outcome measures
| Measure |
Part A- Placebo
n=6 Participants
Subjects received matching placebo under fasted conditions
|
Part A - 5 mg AZD9977
n=6 Participants
Subjects received 5 mg AZD9977, oral suspension under fasted conditions
|
Part A - 25 mg AZD9977
n=6 Participants
Subjects received 25 mg AZD9977, oral suspension under fasted conditions
|
Part A - 100 mg AZD9977
n=5 Participants
Subjects received 100 mg AZD9977, oral suspension under fasted conditions
|
Part A - 200 mg AZD9977
n=5 Participants
Subjects received 200 mg AZD9977, oral suspension under fasted conditions
|
Part A - 400 mg AZD9977
n=2 Participants
Subjects received 400 mg AZD9977, oral suspension under fasted conditions
|
Part A - 800 mg AZD9977
n=5 Participants
Subjects received 800 mg AZD9977, oral suspension under fasted conditions
|
Part A - 800 mg AZD9977 (Split Doses)
n=4 Participants
Subjects received 800 mg AZD9977 (split doses), oral suspension under fasted conditions
|
Part A - 1200 mg AZD9977 (Split Doses)
n=4 Participants
Subjects received 1200 mg AZD9977 (split doses), oral suspension under fasted conditions
|
Part B
n=7 Participants
Subjects received a single dose of AZD9977, under fasted conditions, on two occasions (40 mg AZD9977, IntelliCap device and 40 mg AZD9977, oral solution) separated by a washout period of at least 7 days
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Half-life Associated With Terminal Slope (λz) of a Semi-logarithmic Concentration-time Curve (t1/2λz)
|
1.741 Hour (h)
Standard Deviation 0.1753
|
1.755 Hour (h)
Standard Deviation 0.2923
|
7.161 Hour (h)
Standard Deviation 4.397
|
10.00 Hour (h)
Standard Deviation 1.933
|
9.618 Hour (h)
Standard Deviation 3.412
|
22.99 Hour (h)
Standard Deviation 6.527
|
21.17 Hour (h)
Standard Deviation 12.18
|
21.68 Hour (h)
Standard Deviation 3.495
|
11.60 Hour (h)
Standard Deviation 6.081
|
6.145 Hour (h)
Standard Deviation 3.365
|
SECONDARY outcome
Timeframe: Pre-dose and post-dose upto 48 hrsPopulation: The PK analysis set for Part A consisted of all subjects in the safety analysis set who received one dose of AZD9977 and had evaluable PK data. The PK analysis set for Part B consisted of all subjects in the safety analysis set who received at least one dose of AZD9977 and had evaluable PK data in at least one period.
To assess plasma pharmacokinetic parameters following single ascending doses of AZD977
Outcome measures
| Measure |
Part A- Placebo
n=6 Participants
Subjects received matching placebo under fasted conditions
|
Part A - 5 mg AZD9977
n=6 Participants
Subjects received 5 mg AZD9977, oral suspension under fasted conditions
|
Part A - 25 mg AZD9977
n=6 Participants
Subjects received 25 mg AZD9977, oral suspension under fasted conditions
|
Part A - 100 mg AZD9977
n=5 Participants
Subjects received 100 mg AZD9977, oral suspension under fasted conditions
|
Part A - 200 mg AZD9977
n=5 Participants
Subjects received 200 mg AZD9977, oral suspension under fasted conditions
|
Part A - 400 mg AZD9977
n=2 Participants
Subjects received 400 mg AZD9977, oral suspension under fasted conditions
|
Part A - 800 mg AZD9977
n=5 Participants
Subjects received 800 mg AZD9977, oral suspension under fasted conditions
|
Part A - 800 mg AZD9977 (Split Doses)
n=4 Participants
Subjects received 800 mg AZD9977 (split doses), oral suspension under fasted conditions
|
Part A - 1200 mg AZD9977 (Split Doses)
n=4 Participants
Subjects received 1200 mg AZD9977 (split doses), oral suspension under fasted conditions
|
Part B
n=7 Participants
Subjects received a single dose of AZD9977, under fasted conditions, on two occasions (40 mg AZD9977, IntelliCap device and 40 mg AZD9977, oral solution) separated by a washout period of at least 7 days
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Apparent Clearance (CL/F)
|
24.52 L/h
Standard Deviation 3.391
|
25.89 L/h
Standard Deviation 5.546
|
28.46 L/h
Standard Deviation 11.08
|
21.84 L/h
Standard Deviation 5.812
|
28.49 L/h
Standard Deviation 7.392
|
54.34 L/h
Standard Deviation 19.16
|
20.99 L/h
Standard Deviation 6.683
|
29.38 L/h
Standard Deviation 8.430
|
45.97 L/h
Standard Deviation 13.03
|
31.82 L/h
Standard Deviation 10.79
|
SECONDARY outcome
Timeframe: Pre-dose and post-dose upto 48 hrsPopulation: The PK analysis set for Part A consisted of all subjects in the safety analysis set who received one dose of AZD9977 and had evaluable PK data. The PK analysis set for Part B consisted of all subjects in the safety analysis set who received at least one dose of AZD9977 and had evaluable PK data in at least one period.
To assess plasma pharmacokinetic parameters following single ascending doses of AZD977
Outcome measures
| Measure |
Part A- Placebo
n=6 Participants
Subjects received matching placebo under fasted conditions
|
Part A - 5 mg AZD9977
n=6 Participants
Subjects received 5 mg AZD9977, oral suspension under fasted conditions
|
Part A - 25 mg AZD9977
n=6 Participants
Subjects received 25 mg AZD9977, oral suspension under fasted conditions
|
Part A - 100 mg AZD9977
n=5 Participants
Subjects received 100 mg AZD9977, oral suspension under fasted conditions
|
Part A - 200 mg AZD9977
n=5 Participants
Subjects received 200 mg AZD9977, oral suspension under fasted conditions
|
Part A - 400 mg AZD9977
n=2 Participants
Subjects received 400 mg AZD9977, oral suspension under fasted conditions
|
Part A - 800 mg AZD9977
n=5 Participants
Subjects received 800 mg AZD9977, oral suspension under fasted conditions
|
Part A - 800 mg AZD9977 (Split Doses)
n=4 Participants
Subjects received 800 mg AZD9977 (split doses), oral suspension under fasted conditions
|
Part A - 1200 mg AZD9977 (Split Doses)
n=4 Participants
Subjects received 1200 mg AZD9977 (split doses), oral suspension under fasted conditions
|
Part B
n=7 Participants
Subjects received a single dose of AZD9977, under fasted conditions, on two occasions (40 mg AZD9977, IntelliCap device and 40 mg AZD9977, oral solution) separated by a washout period of at least 7 days
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Apparent Volume of Distribution (Vz/F)
|
61.50 L
Standard Deviation 9.724
|
64.52 L
Standard Deviation 13.40
|
266.1 L
Standard Deviation 180.6
|
315.8 L
Standard Deviation 111.9
|
401.9 L
Standard Deviation 180.0
|
1712 L
Standard Deviation 123.7
|
652.5 L
Standard Deviation 414.0
|
897.0 L
Standard Deviation 210.6
|
720.1 L
Standard Deviation 348.2
|
269.4 L
Standard Deviation 142.2
|
SECONDARY outcome
Timeframe: Pre-dose and post-dose upto 48 hrsPopulation: The PK analysis set for Part A consisted of all subjects in the safety analysis set who received one dose of AZD9977 and had evaluable PK data. The PK analysis set for Part B consisted of all subjects in the safety analysis set who received at least one dose of AZD9977 and had evaluable PK data in at least one period.
To assess urine pharmacokinetic parameters following single ascending doses of AZD9977
Outcome measures
| Measure |
Part A- Placebo
n=6 Participants
Subjects received matching placebo under fasted conditions
|
Part A - 5 mg AZD9977
n=6 Participants
Subjects received 5 mg AZD9977, oral suspension under fasted conditions
|
Part A - 25 mg AZD9977
n=6 Participants
Subjects received 25 mg AZD9977, oral suspension under fasted conditions
|
Part A - 100 mg AZD9977
n=5 Participants
Subjects received 100 mg AZD9977, oral suspension under fasted conditions
|
Part A - 200 mg AZD9977
n=6 Participants
Subjects received 200 mg AZD9977, oral suspension under fasted conditions
|
Part A - 400 mg AZD9977
n=5 Participants
Subjects received 400 mg AZD9977, oral suspension under fasted conditions
|
Part A - 800 mg AZD9977
n=6 Participants
Subjects received 800 mg AZD9977, oral suspension under fasted conditions
|
Part A - 800 mg AZD9977 (Split Doses)
n=5 Participants
Subjects received 800 mg AZD9977 (split doses), oral suspension under fasted conditions
|
Part A - 1200 mg AZD9977 (Split Doses)
Subjects received 1200 mg AZD9977 (split doses), oral suspension under fasted conditions
|
Part B
Subjects received a single dose of AZD9977, under fasted conditions, on two occasions (40 mg AZD9977, IntelliCap device and 40 mg AZD9977, oral solution) separated by a washout period of at least 7 days
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Cumulative Amount of Unchanged Drug Excreted Into Urine [Ae (0-48)]
|
2491 nmol
Standard Deviation 213.4
|
12440 nmol
Standard Deviation 2818
|
59700 nmol
Standard Deviation 21910
|
122800 nmol
Standard Deviation 27020
|
189700 nmol
Standard Deviation 46420
|
178600 nmol
Standard Deviation 32530
|
428600 nmol
Standard Deviation 93430
|
503400 nmol
Standard Deviation 132300
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and post-dose upto 48 hrsPopulation: The PK analysis set for Part A consisted of all subjects in the safety analysis set who received one dose of AZD9977 and had evaluable PK data. The PK analysis set for Part B consisted of all subjects in the safety analysis set who received at least one dose of AZD9977 and had evaluable PK data in at least one period.
To assess percentage of the total drug excreted in the urine that was unchanged following single ascending doses of AZD9977
Outcome measures
| Measure |
Part A- Placebo
n=6 Participants
Subjects received matching placebo under fasted conditions
|
Part A - 5 mg AZD9977
n=6 Participants
Subjects received 5 mg AZD9977, oral suspension under fasted conditions
|
Part A - 25 mg AZD9977
n=6 Participants
Subjects received 25 mg AZD9977, oral suspension under fasted conditions
|
Part A - 100 mg AZD9977
n=5 Participants
Subjects received 100 mg AZD9977, oral suspension under fasted conditions
|
Part A - 200 mg AZD9977
n=6 Participants
Subjects received 200 mg AZD9977, oral suspension under fasted conditions
|
Part A - 400 mg AZD9977
n=5 Participants
Subjects received 400 mg AZD9977, oral suspension under fasted conditions
|
Part A - 800 mg AZD9977
n=6 Participants
Subjects received 800 mg AZD9977, oral suspension under fasted conditions
|
Part A - 800 mg AZD9977 (Split Doses)
n=5 Participants
Subjects received 800 mg AZD9977 (split doses), oral suspension under fasted conditions
|
Part A - 1200 mg AZD9977 (Split Doses)
Subjects received 1200 mg AZD9977 (split doses), oral suspension under fasted conditions
|
Part B
Subjects received a single dose of AZD9977, under fasted conditions, on two occasions (40 mg AZD9977, IntelliCap device and 40 mg AZD9977, oral solution) separated by a washout period of at least 7 days
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Fraction Excreted Unchanged in Urine[Fe (0-48)]
|
19.90 Percentage
Standard Deviation 1.705
|
19.88 Percentage
Standard Deviation 4.502
|
23.84 Percentage
Standard Deviation 8.750
|
24.53 Percentage
Standard Deviation 5.396
|
18.94 Percentage
Standard Deviation 4.635
|
8.917 Percentage
Standard Deviation 1.624
|
21.40 Percentage
Standard Deviation 4.664
|
16.75 Percentage
Standard Deviation 4.402
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and post-dose upto 48 hrsPopulation: The PK analysis set for Part A consisted of all subjects in the safety analysis set who received one dose of AZD9977 and had evaluable PK data. The PK analysis set for Part B consisted of all subjects in the safety analysis set who received at least one dose of AZD9977 and had evaluable PK data in at least one period.
To assess urine pharmacokinetic parameters following single ascending doses of AZD9977
Outcome measures
| Measure |
Part A- Placebo
n=6 Participants
Subjects received matching placebo under fasted conditions
|
Part A - 5 mg AZD9977
n=6 Participants
Subjects received 5 mg AZD9977, oral suspension under fasted conditions
|
Part A - 25 mg AZD9977
n=6 Participants
Subjects received 25 mg AZD9977, oral suspension under fasted conditions
|
Part A - 100 mg AZD9977
n=5 Participants
Subjects received 100 mg AZD9977, oral suspension under fasted conditions
|
Part A - 200 mg AZD9977
n=6 Participants
Subjects received 200 mg AZD9977, oral suspension under fasted conditions
|
Part A - 400 mg AZD9977
n=5 Participants
Subjects received 400 mg AZD9977, oral suspension under fasted conditions
|
Part A - 800 mg AZD9977
n=6 Participants
Subjects received 800 mg AZD9977, oral suspension under fasted conditions
|
Part A - 800 mg AZD9977 (Split Doses)
n=5 Participants
Subjects received 800 mg AZD9977 (split doses), oral suspension under fasted conditions
|
Part A - 1200 mg AZD9977 (Split Doses)
Subjects received 1200 mg AZD9977 (split doses), oral suspension under fasted conditions
|
Part B
Subjects received a single dose of AZD9977, under fasted conditions, on two occasions (40 mg AZD9977, IntelliCap device and 40 mg AZD9977, oral solution) separated by a washout period of at least 7 days
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Renal Clearance of Drug From Plasma [CLR (0-48)]
|
5.018 L/h
Standard Deviation 0.5818
|
5.061 L/h
Standard Deviation 1.195
|
6.114 L/h
Standard Deviation 1.533
|
5.230 L/h
Standard Deviation 1.028
|
5.371 L/h
Standard Deviation 0.6880
|
5.700 L/h
Standard Deviation 1.097
|
5.274 L/h
Standard Deviation 0.9817
|
5.319 L/h
Standard Deviation 0.5086
|
—
|
—
|
Adverse Events
Part A- Placebo
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Part A - 5 mg AZD9977
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part A - 25 mg AZD9977
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part A - 100 mg AZD9977
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part A - 200 mg AZD9977
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part A - 400 mg AZD9977
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part A - 800 mg AZD9977
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part A - 800 mg AZD9977 (Split Doses)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part A - 1200 mg AZD9977 (Split Doses)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part B
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- Placebo
n=16 participants at risk
Subjects received matching placebo under fasted conditions
|
Part A - 5 mg AZD9977
n=6 participants at risk
Subjects received 5 mg AZD9977, oral suspension under fasted conditions
|
Part A - 25 mg AZD9977
n=6 participants at risk
Subjects received 25 mg AZD9977, oral suspension under fasted conditions
|
Part A - 100 mg AZD9977
n=6 participants at risk
Subjects received 100 mg AZD9977, oral suspension under fasted conditions
|
Part A - 200 mg AZD9977
n=5 participants at risk
Subjects received 200 mg AZD9977, oral suspension under fasted conditions
|
Part A - 400 mg AZD9977
n=6 participants at risk
Subjects received 400 mg AZD9977, oral suspension under fasted conditions
|
Part A - 800 mg AZD9977
n=5 participants at risk
Subjects received 800 mg AZD9977, oral suspension under fasted conditions
|
Part A - 800 mg AZD9977 (Split Doses)
n=6 participants at risk
Subjects received 800 mg AZD9977 (split doses), oral suspension under fasted conditions
|
Part A - 1200 mg AZD9977 (Split Doses)
n=6 participants at risk
Subjects received 1200 mg AZD9977 (split doses), oral suspension under fasted conditions
|
Part B
n=8 participants at risk
Subjects received a single dose of AZD9977, under fasted conditions, on two occasions (40 mg AZD9977, IntelliCap device and 40 mg AZD9977, oral solution) separated by a washout period of at least 7 days
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Dizziness
|
6.2%
1/16 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
16.7%
1/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
16.7%
1/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
20.0%
1/5 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/5 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/8 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
|
Nervous system disorders
Headache
|
6.2%
1/16 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
16.7%
1/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/5 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/5 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
12.5%
1/8 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
|
Nervous system disorders
Presyncope
|
6.2%
1/16 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/5 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/5 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/8 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
|
Musculoskeletal and connective tissue disorders
Backpain
|
0.00%
0/16 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
16.7%
1/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/5 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
16.7%
1/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/5 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/8 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/16 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/5 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
16.7%
1/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/5 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/8 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
|
Musculoskeletal and connective tissue disorders
Myalgia intercostal
|
6.2%
1/16 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/5 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/5 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/8 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/16 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
16.7%
1/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/5 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/5 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/8 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/16 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
16.7%
1/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/5 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/5 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
12.5%
1/8 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/16 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/5 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/5 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
12.5%
1/8 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/16 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/5 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/5 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
12.5%
1/8 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
|
Gastrointestinal disorders
Feces soft
|
0.00%
0/16 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/5 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/5 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
12.5%
1/8 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/16 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/5 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/5 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
16.7%
1/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/8 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/16 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/5 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/5 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
16.7%
1/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/8 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
12.5%
2/16 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/5 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/5 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
12.5%
1/8 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
|
General disorders
Feeling hot
|
0.00%
0/16 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/5 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/5 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
16.7%
1/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/8 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
|
General disorders
Thirst
|
6.2%
1/16 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/5 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/5 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/8 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/16 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/5 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/5 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
16.7%
1/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
25.0%
2/8 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/16 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/5 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/5 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
16.7%
1/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/8 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
|
Injury, poisoning and procedural complications
Contusion
|
12.5%
2/16 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/5 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/5 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/8 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
|
Injury, poisoning and procedural complications
Face injury
|
0.00%
0/16 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/5 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/5 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
0.00%
0/6 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
12.5%
1/8 • SAEs will be collected from the signing of informed consent and AEs from randomization until the final follow-up visit in Part A, and from first dosing until the final follow-up visit in Part B.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If a publication (e.g., in a scientific journal) based on the results of this study is envisaged, approval from AstraZeneca will be obtained and a draft manuscript will be submitted to AstraZeneca for scrutiny and comment. The choice of conduit will be mutually agreed on by the Principal Investigator and AstraZeneca.
- Publication restrictions are in place
Restriction type: OTHER