Trial Outcomes & Findings for A Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD4041 in Healthy Volunteers (NCT NCT04076540)
NCT ID: NCT04076540
Last Updated: 2024-07-17
Results Overview
Number of participants experiencing any adverse event
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
48 participants
Primary outcome timeframe
6 weeks
Results posted on
2024-07-17
Participant Flow
Participant milestones
| Measure |
Pooled Placebo
Single dose oral solution pooled from 6 cohorts
|
AZD4041 X mg
Single dose oral solution
|
AZD4041 3X mg
Single dose oral solution
|
AZD4041 9X mg
Single dose oral solution
|
AZD4041 20X mg
Single dose oral solution
|
AZD4041 40X mg
Single dose oral solution
|
AZD4041 80X mg
Single dose oral solution
|
|---|---|---|---|---|---|---|---|
|
Cohort 1: Dose Level X
STARTED
|
2
|
6
|
0
|
0
|
0
|
0
|
0
|
|
Cohort 1: Dose Level X
COMPLETED
|
2
|
6
|
0
|
0
|
0
|
0
|
0
|
|
Cohort 1: Dose Level X
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Cohort 2: Dose Level 3X
STARTED
|
2
|
0
|
6
|
0
|
0
|
0
|
0
|
|
Cohort 2: Dose Level 3X
COMPLETED
|
2
|
0
|
6
|
0
|
0
|
0
|
0
|
|
Cohort 2: Dose Level 3X
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Cohort 3: Dose Level 9X
STARTED
|
2
|
0
|
0
|
6
|
0
|
0
|
0
|
|
Cohort 3: Dose Level 9X
COMPLETED
|
2
|
0
|
0
|
6
|
0
|
0
|
0
|
|
Cohort 3: Dose Level 9X
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Cohort 4: Dose Level 20X
STARTED
|
2
|
0
|
0
|
0
|
6
|
0
|
0
|
|
Cohort 4: Dose Level 20X
COMPLETED
|
2
|
0
|
0
|
0
|
6
|
0
|
0
|
|
Cohort 4: Dose Level 20X
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Cohort 5: Dose Level 40X
STARTED
|
2
|
0
|
0
|
0
|
0
|
6
|
0
|
|
Cohort 5: Dose Level 40X
COMPLETED
|
2
|
0
|
0
|
0
|
0
|
6
|
0
|
|
Cohort 5: Dose Level 40X
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Cohort 6: Dose Level 80X
STARTED
|
2
|
0
|
0
|
0
|
0
|
0
|
6
|
|
Cohort 6: Dose Level 80X
COMPLETED
|
2
|
0
|
0
|
0
|
0
|
0
|
6
|
|
Cohort 6: Dose Level 80X
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD4041 in Healthy Volunteers
Baseline characteristics by cohort
| Measure |
Pooled Placebo
n=12 Participants
Single dose oral solution pooled from 6 cohorts
|
AZD4041 X mg
n=6 Participants
Single dose oral solution
|
AZD4041 3X mg
n=6 Participants
Single dose oral solution
|
AZD4041 9X mg
n=6 Participants
Single dose oral solution
|
AZD4041 20X mg
n=6 Participants
Single dose oral solution
|
AZD4041 40X mg
n=6 Participants
Single dose oral solution
|
AZD4041 80X mg
n=6 Participants
Single dose oral solution
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
46.6 Years
STANDARD_DEVIATION 12.26 • n=99 Participants
|
49.8 Years
STANDARD_DEVIATION 11.81 • n=107 Participants
|
37.3 Years
STANDARD_DEVIATION 14.49 • n=206 Participants
|
46.0 Years
STANDARD_DEVIATION 14.99 • n=7 Participants
|
55.5 Years
STANDARD_DEVIATION 4.85 • n=31 Participants
|
46.2 Years
STANDARD_DEVIATION 8.68 • n=30 Participants
|
53.5 Years
STANDARD_DEVIATION 11.67 • n=3 Participants
|
47.7 Years
STANDARD_DEVIATION 50.5 • n=6 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
4 Participants
n=30 Participants
|
5 Participants
n=3 Participants
|
25 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
23 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
3 Participants
n=3 Participants
|
17 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
4 Participants
n=30 Participants
|
3 Participants
n=3 Participants
|
31 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
11 Participants
n=6 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
5 Participants
n=30 Participants
|
5 Participants
n=3 Participants
|
34 Participants
n=6 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
|
Weight
|
75.45 kg
STANDARD_DEVIATION 10.62 • n=99 Participants
|
75.23 kg
STANDARD_DEVIATION 13.923 • n=107 Participants
|
69.47 kg
STANDARD_DEVIATION 9.92 • n=206 Participants
|
74.37 kg
STANDARD_DEVIATION 14.05 • n=7 Participants
|
67.62 kg
STANDARD_DEVIATION 15.47 • n=31 Participants
|
78.58 kg
STANDARD_DEVIATION 8.63 • n=30 Participants
|
61.03 kg
STANDARD_DEVIATION 10.28 • n=3 Participants
|
72.15 kg
STANDARD_DEVIATION 12.34 • n=6 Participants
|
|
Height
|
169.96 cm
STANDARD_DEVIATION 9.37 • n=99 Participants
|
166.13 cm
STANDARD_DEVIATION 12.51 • n=107 Participants
|
167.70 cm
STANDARD_DEVIATION 8.31 • n=206 Participants
|
165.17 cm
STANDARD_DEVIATION 9.55 • n=7 Participants
|
164.88 cm
STANDARD_DEVIATION 9.160 • n=31 Participants
|
174.40 cm
STANDARD_DEVIATION 6.53 • n=30 Participants
|
159.02 cm
STANDARD_DEVIATION 9.42 • n=3 Participants
|
167.15 cm
STANDARD_DEVIATION 9.78 • n=6 Participants
|
|
Body Mass Index (BMI)
|
26.14 kg/m^2
STANDARD_DEVIATION 3.11 • n=99 Participants
|
27.02 kg/m^2
STANDARD_DEVIATION 1.87 • n=107 Participants
|
24.63 kg/m^2
STANDARD_DEVIATION 2.60 • n=206 Participants
|
27.07 kg/m^2
STANDARD_DEVIATION 2.72 • n=7 Participants
|
24.68 kg/m^2
STANDARD_DEVIATION 3.84 • n=31 Participants
|
25.85 kg/m^2
STANDARD_DEVIATION 2.50 • n=30 Participants
|
24.00 kg/m^2
STANDARD_DEVIATION 2.03 • n=3 Participants
|
25.69 kg/m^2
STANDARD_DEVIATION 2.82 • n=6 Participants
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: Safety Analysis Set
Number of participants experiencing any adverse event
Outcome measures
| Measure |
AZD4041 40X mg
n=6 Participants
Single dose oral solution
|
AZD4041 80X mg
n=6 Participants
Single dose oral solution
|
Pooled Placebo
n=12 Participants
Single dose oral solution pooled from 6 cohorts
|
AZD4041 X mg
n=6 Participants
Single dose oral solution
|
AZD4041 3X mg
n=6 Participants
Single dose oral solution
|
AZD4041 9X mg
n=6 Participants
Single dose oral solution
|
AZD4041 80X mg
n=6 Participants
Single dose oral solution
|
|---|---|---|---|---|---|---|---|
|
Number of Adverse Events
|
1 Participants
|
3 Participants
|
5 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: Safety Analysis Set
Number of participants experiencing any treatment emergent adverse events
Outcome measures
| Measure |
AZD4041 40X mg
n=6 Participants
Single dose oral solution
|
AZD4041 80X mg
n=6 Participants
Single dose oral solution
|
Pooled Placebo
n=12 Participants
Single dose oral solution pooled from 6 cohorts
|
AZD4041 X mg
n=6 Participants
Single dose oral solution
|
AZD4041 3X mg
n=6 Participants
Single dose oral solution
|
AZD4041 9X mg
n=6 Participants
Single dose oral solution
|
AZD4041 80X mg
n=6 Participants
Single dose oral solution
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
|
1 Participants
|
3 Participants
|
5 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: Safety Analysis Set
Number of participants experiencing any treatment-related TEAEs
Outcome measures
| Measure |
AZD4041 40X mg
n=6 Participants
Single dose oral solution
|
AZD4041 80X mg
n=6 Participants
Single dose oral solution
|
Pooled Placebo
n=12 Participants
Single dose oral solution pooled from 6 cohorts
|
AZD4041 X mg
n=6 Participants
Single dose oral solution
|
AZD4041 3X mg
n=6 Participants
Single dose oral solution
|
AZD4041 9X mg
n=6 Participants
Single dose oral solution
|
AZD4041 80X mg
n=6 Participants
Single dose oral solution
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-Related TEAEs
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: Safety Analysis Set
Number of participants experiencing any moderate TEAEs
Outcome measures
| Measure |
AZD4041 40X mg
n=6 Participants
Single dose oral solution
|
AZD4041 80X mg
n=6 Participants
Single dose oral solution
|
Pooled Placebo
n=12 Participants
Single dose oral solution pooled from 6 cohorts
|
AZD4041 X mg
n=6 Participants
Single dose oral solution
|
AZD4041 3X mg
n=6 Participants
Single dose oral solution
|
AZD4041 9X mg
n=6 Participants
Single dose oral solution
|
AZD4041 80X mg
n=6 Participants
Single dose oral solution
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Moderate TEAEs
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: Safety Analysis Set
Number of participants experiencing any treatment-related moderate TEAEs
Outcome measures
| Measure |
AZD4041 40X mg
n=6 Participants
Single dose oral solution
|
AZD4041 80X mg
n=6 Participants
Single dose oral solution
|
Pooled Placebo
n=12 Participants
Single dose oral solution pooled from 6 cohorts
|
AZD4041 X mg
n=6 Participants
Single dose oral solution
|
AZD4041 3X mg
n=6 Participants
Single dose oral solution
|
AZD4041 9X mg
n=6 Participants
Single dose oral solution
|
AZD4041 80X mg
n=6 Participants
Single dose oral solution
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-Related Moderate TEAEs
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: Safety Analysis Set
Number of participants experiencing any severe TEAEs
Outcome measures
| Measure |
AZD4041 40X mg
n=6 Participants
Single dose oral solution
|
AZD4041 80X mg
n=6 Participants
Single dose oral solution
|
Pooled Placebo
n=12 Participants
Single dose oral solution pooled from 6 cohorts
|
AZD4041 X mg
n=6 Participants
Single dose oral solution
|
AZD4041 3X mg
n=6 Participants
Single dose oral solution
|
AZD4041 9X mg
n=6 Participants
Single dose oral solution
|
AZD4041 80X mg
n=6 Participants
Single dose oral solution
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Severe TEAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: Safety Analysis Set
Number of participants experiencing any treatment-related severe TEAEs
Outcome measures
| Measure |
AZD4041 40X mg
n=6 Participants
Single dose oral solution
|
AZD4041 80X mg
n=6 Participants
Single dose oral solution
|
Pooled Placebo
n=12 Participants
Single dose oral solution pooled from 6 cohorts
|
AZD4041 X mg
n=6 Participants
Single dose oral solution
|
AZD4041 3X mg
n=6 Participants
Single dose oral solution
|
AZD4041 9X mg
n=6 Participants
Single dose oral solution
|
AZD4041 80X mg
n=6 Participants
Single dose oral solution
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-Related Severe TEAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: Safety Analysis Set
Number of participants experiencing any serious adverse events (SAEs)
Outcome measures
| Measure |
AZD4041 40X mg
n=6 Participants
Single dose oral solution
|
AZD4041 80X mg
n=6 Participants
Single dose oral solution
|
Pooled Placebo
n=12 Participants
Single dose oral solution pooled from 6 cohorts
|
AZD4041 X mg
n=6 Participants
Single dose oral solution
|
AZD4041 3X mg
n=6 Participants
Single dose oral solution
|
AZD4041 9X mg
n=6 Participants
Single dose oral solution
|
AZD4041 80X mg
n=6 Participants
Single dose oral solution
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: Safety Analysis Set
Number of participants experiencing any treatment-related serious adverse events (SAEs)
Outcome measures
| Measure |
AZD4041 40X mg
n=6 Participants
Single dose oral solution
|
AZD4041 80X mg
n=6 Participants
Single dose oral solution
|
Pooled Placebo
n=12 Participants
Single dose oral solution pooled from 6 cohorts
|
AZD4041 X mg
n=6 Participants
Single dose oral solution
|
AZD4041 3X mg
n=6 Participants
Single dose oral solution
|
AZD4041 9X mg
n=6 Participants
Single dose oral solution
|
AZD4041 80X mg
n=6 Participants
Single dose oral solution
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-Related SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: Safety Analysis Set
Number of participants with treatment-emergent adverse events leading to early discontinuation
Outcome measures
| Measure |
AZD4041 40X mg
n=6 Participants
Single dose oral solution
|
AZD4041 80X mg
n=6 Participants
Single dose oral solution
|
Pooled Placebo
n=12 Participants
Single dose oral solution pooled from 6 cohorts
|
AZD4041 X mg
n=6 Participants
Single dose oral solution
|
AZD4041 3X mg
n=6 Participants
Single dose oral solution
|
AZD4041 9X mg
n=6 Participants
Single dose oral solution
|
AZD4041 80X mg
n=6 Participants
Single dose oral solution
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With TEAEs Leading to Early Discontinuation
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: Safety Analysis Set
Number of participants who died
Outcome measures
| Measure |
AZD4041 40X mg
n=6 Participants
Single dose oral solution
|
AZD4041 80X mg
n=6 Participants
Single dose oral solution
|
Pooled Placebo
n=12 Participants
Single dose oral solution pooled from 6 cohorts
|
AZD4041 X mg
n=6 Participants
Single dose oral solution
|
AZD4041 3X mg
n=6 Participants
Single dose oral solution
|
AZD4041 9X mg
n=6 Participants
Single dose oral solution
|
AZD4041 80X mg
n=6 Participants
Single dose oral solution
|
|---|---|---|---|---|---|---|---|
|
Number of Participant Deaths
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: Safety Analysis Set
Number of participants with treatment-related abnormal vital signs considered clinically significant or reported as a treatment-emergent adverse event by the investigator.
Outcome measures
| Measure |
AZD4041 40X mg
n=6 Participants
Single dose oral solution
|
AZD4041 80X mg
n=6 Participants
Single dose oral solution
|
Pooled Placebo
n=12 Participants
Single dose oral solution pooled from 6 cohorts
|
AZD4041 X mg
n=6 Participants
Single dose oral solution
|
AZD4041 3X mg
n=6 Participants
Single dose oral solution
|
AZD4041 9X mg
n=6 Participants
Single dose oral solution
|
AZD4041 80X mg
n=6 Participants
Single dose oral solution
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Abnormal Vital Signs
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: Safety Analysis Set
Number of participants with treatment-related abnormal blood pressure considered clinically significant or reported as a treatment-emergent adverse event by the investigator
Outcome measures
| Measure |
AZD4041 40X mg
n=6 Participants
Single dose oral solution
|
AZD4041 80X mg
n=6 Participants
Single dose oral solution
|
Pooled Placebo
n=12 Participants
Single dose oral solution pooled from 6 cohorts
|
AZD4041 X mg
n=6 Participants
Single dose oral solution
|
AZD4041 3X mg
n=6 Participants
Single dose oral solution
|
AZD4041 9X mg
n=6 Participants
Single dose oral solution
|
AZD4041 80X mg
n=6 Participants
Single dose oral solution
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Abnormal Vital Signs (Blood Pressure)
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: Safety Analysis Set
Number of participants with treatment-related abnormal heart rate considered clinically significant or reported as a treatment-emergent adverse event by the investigator
Outcome measures
| Measure |
AZD4041 40X mg
n=6 Participants
Single dose oral solution
|
AZD4041 80X mg
n=6 Participants
Single dose oral solution
|
Pooled Placebo
n=12 Participants
Single dose oral solution pooled from 6 cohorts
|
AZD4041 X mg
n=6 Participants
Single dose oral solution
|
AZD4041 3X mg
n=6 Participants
Single dose oral solution
|
AZD4041 9X mg
n=6 Participants
Single dose oral solution
|
AZD4041 80X mg
n=6 Participants
Single dose oral solution
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Abnormal Vital Signs (Heart Rate)
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline and Day 1Population: Safety Analysis Set
Measured by standing pulse rate at baseline and 2 hours post
Outcome measures
| Measure |
AZD4041 40X mg
n=6 Participants
Single dose oral solution
|
AZD4041 80X mg
n=6 Participants
Single dose oral solution
|
Pooled Placebo
n=12 Participants
Single dose oral solution pooled from 6 cohorts
|
AZD4041 X mg
n=6 Participants
Single dose oral solution
|
AZD4041 3X mg
n=6 Participants
Single dose oral solution
|
AZD4041 9X mg
n=6 Participants
Single dose oral solution
|
AZD4041 80X mg
n=6 Participants
Single dose oral solution
|
|---|---|---|---|---|---|---|---|
|
Pulse Rate at Baseline and Day 1 2 Hours Post.
Baseline
|
83.5 Beats per minute
Standard Deviation 10.01
|
78.2 Beats per minute
Standard Deviation 9.43
|
77.8 Beats per minute
Standard Deviation 9.53
|
74.8 Beats per minute
Standard Deviation 8.45
|
82.2 Beats per minute
Standard Deviation 9.77
|
90.7 Beats per minute
Standard Deviation 7.34
|
82.3 Beats per minute
Standard Deviation 23.95
|
|
Pulse Rate at Baseline and Day 1 2 Hours Post.
Day 1 (2 hours)
|
78.2 Beats per minute
Standard Deviation 10.05
|
82.0 Beats per minute
Standard Deviation 18.31
|
81.7 Beats per minute
Standard Deviation 14.18
|
80.2 Beats per minute
Standard Deviation 8.04
|
83.7 Beats per minute
Standard Deviation 10.13
|
102.8 Beats per minute
Standard Deviation 31.16
|
90.3 Beats per minute
Standard Deviation 15.71
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: Safety Analysis Set
Number of participants with treatment-related abnormal hematology values considered clinically significant or reported as a treatment-emergent adverse event by the investigator
Outcome measures
| Measure |
AZD4041 40X mg
n=6 Participants
Single dose oral solution
|
AZD4041 80X mg
n=6 Participants
Single dose oral solution
|
Pooled Placebo
n=12 Participants
Single dose oral solution pooled from 6 cohorts
|
AZD4041 X mg
n=6 Participants
Single dose oral solution
|
AZD4041 3X mg
n=6 Participants
Single dose oral solution
|
AZD4041 9X mg
n=6 Participants
Single dose oral solution
|
AZD4041 80X mg
n=6 Participants
Single dose oral solution
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Abnormal Safety Laboratory Tests (Hematology)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: Safety Analysis Set
Number of participants with treatment-related abnormal serum chemistry values considered clinically significant or reported as a treatment-emergent adverse event by the investigator
Outcome measures
| Measure |
AZD4041 40X mg
n=6 Participants
Single dose oral solution
|
AZD4041 80X mg
n=6 Participants
Single dose oral solution
|
Pooled Placebo
n=12 Participants
Single dose oral solution pooled from 6 cohorts
|
AZD4041 X mg
n=6 Participants
Single dose oral solution
|
AZD4041 3X mg
n=6 Participants
Single dose oral solution
|
AZD4041 9X mg
n=6 Participants
Single dose oral solution
|
AZD4041 80X mg
n=6 Participants
Single dose oral solution
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Abnormal Safety Laboratory Tests (Serum Chemistry)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: Safety Analysis Set
Number of participants with treatment-related abnormal urinalysis values considered clinically significant or reported as a treatment-emergent adverse event by the investigator
Outcome measures
| Measure |
AZD4041 40X mg
n=6 Participants
Single dose oral solution
|
AZD4041 80X mg
n=6 Participants
Single dose oral solution
|
Pooled Placebo
n=12 Participants
Single dose oral solution pooled from 6 cohorts
|
AZD4041 X mg
n=6 Participants
Single dose oral solution
|
AZD4041 3X mg
n=6 Participants
Single dose oral solution
|
AZD4041 9X mg
n=6 Participants
Single dose oral solution
|
AZD4041 80X mg
n=6 Participants
Single dose oral solution
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Abnormal Safety Laboratory Tests (Urinalysis)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 4 daysPopulation: Safety Analysis Set
Number of participants with abnormal 12-lead electrocardiograms (ECGs), considered clinically significant or reported as a treatment-emergent adverse event by the investigator
Outcome measures
| Measure |
AZD4041 40X mg
n=6 Participants
Single dose oral solution
|
AZD4041 80X mg
n=6 Participants
Single dose oral solution
|
Pooled Placebo
n=12 Participants
Single dose oral solution pooled from 6 cohorts
|
AZD4041 X mg
n=6 Participants
Single dose oral solution
|
AZD4041 3X mg
n=6 Participants
Single dose oral solution
|
AZD4041 9X mg
n=6 Participants
Single dose oral solution
|
AZD4041 80X mg
n=6 Participants
Single dose oral solution
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Abnormal 12-lead ECGs
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Thru Day 4Population: Safety Analysis Set
Measured by digital electrocardiograms (ECGs)
Outcome measures
| Measure |
AZD4041 40X mg
n=6 Participants
Single dose oral solution
|
AZD4041 80X mg
n=6 Participants
Single dose oral solution
|
Pooled Placebo
n=12 Participants
Single dose oral solution pooled from 6 cohorts
|
AZD4041 X mg
n=6 Participants
Single dose oral solution
|
AZD4041 3X mg
n=6 Participants
Single dose oral solution
|
AZD4041 9X mg
n=6 Participants
Single dose oral solution
|
AZD4041 80X mg
n=6 Participants
Single dose oral solution
|
|---|---|---|---|---|---|---|---|
|
Heart Rate at Baseline and Times Post Dose
Day 2 (36 hours)
|
73.0 Beats per minute
Standard Deviation 10.1
|
67.8 Beats per minute
Standard Deviation 8.9
|
65.0 Beats per minute
Standard Deviation 7.2
|
65.5 Beats per minute
Standard Deviation 8.3
|
61.2 Beats per minute
Standard Deviation 4.6
|
71.0 Beats per minute
Standard Deviation 9.6
|
61.0 Beats per minute
Standard Deviation 9.6
|
|
Heart Rate at Baseline and Times Post Dose
Baseline
|
64.2 Beats per minute
Standard Deviation 4.9
|
66.0 Beats per minute
Standard Deviation 6.3
|
60.7 Beats per minute
Standard Deviation 6.5
|
63.0 Beats per minute
Standard Deviation 4.0
|
53.7 Beats per minute
Standard Deviation 5.4
|
67.3 Beats per minute
Standard Deviation 5.7
|
61.7 Beats per minute
Standard Deviation 8.21
|
|
Heart Rate at Baseline and Times Post Dose
Day 1 (0.5 hour)
|
65.3 Beats per minute
Standard Deviation 6.7
|
61.2 Beats per minute
Standard Deviation 6.4
|
58.6 Beats per minute
Standard Deviation 4.7
|
64.0 Beats per minute
Standard Deviation 4.3
|
55.8 Beats per minute
Standard Deviation 5.0
|
67.8 Beats per minute
Standard Deviation 8.9
|
57.7 Beats per minute
Standard Deviation 8.24
|
|
Heart Rate at Baseline and Times Post Dose
Day 1 (1 hour)
|
62.7 Beats per minute
Standard Deviation 5.2
|
60.8 Beats per minute
Standard Deviation 8.0
|
59.0 Beats per minute
Standard Deviation 5.0
|
62.5 Beats per minute
Standard Deviation 5.8
|
56.2 Beats per minute
Standard Deviation 5.0
|
67.0 Beats per minute
Standard Deviation 8.7
|
67.5 Beats per minute
Standard Deviation 7.4
|
|
Heart Rate at Baseline and Times Post Dose
Day 1 (1.5 hours)
|
62.8 Beats per minute
Standard Deviation 5.9
|
61.7 Beats per minute
Standard Deviation 8.4
|
58.3 Beats per minute
Standard Deviation 5.8
|
62.5 Beats per minute
Standard Deviation 5.6
|
56.0 Beats per minute
Standard Deviation 4.2
|
66.0 Beats per minute
Standard Deviation 9.0
|
57.8 Beats per minute
Standard Deviation 11.2
|
|
Heart Rate at Baseline and Times Post Dose
Day 1 (2 hours)
|
61.7 Beats per minute
Standard Deviation 5.9
|
61.0 Beats per minute
Standard Deviation 8.3
|
57.8 Beats per minute
Standard Deviation 4.8
|
63.2 Beats per minute
Standard Deviation 6.8
|
55.8 Beats per minute
Standard Deviation 7.4
|
67.2 Beats per minute
Standard Deviation 8.8
|
57.8 Beats per minute
Standard Deviation 8.30
|
|
Heart Rate at Baseline and Times Post Dose
Day 1 (3 hours)
|
62.3 Beats per minute
Standard Deviation 5.1
|
63.2 Beats per minute
Standard Deviation 7.0
|
58.0 Beats per minute
Standard Deviation 5.6
|
65.5 Beats per minute
Standard Deviation 6.8
|
56.7 Beats per minute
Standard Deviation 5.16
|
67.0 Beats per minute
Standard Deviation 7.4
|
58.3 Beats per minute
Standard Deviation 9.0
|
|
Heart Rate at Baseline and Times Post Dose
Day 1 (4 hours)
|
64.0 Beats per minute
Standard Deviation 5.1
|
61.0 Beats per minute
Standard Deviation 8.1
|
68.7 Beats per minute
Standard Deviation 5.9
|
64.7 Beats per minute
Standard Deviation 7.2
|
56.5 Beats per minute
Standard Deviation 4.1
|
66.2 Beats per minute
Standard Deviation 7.9
|
57.3 Beats per minute
Standard Deviation 7.8
|
|
Heart Rate at Baseline and Times Post Dose
Day 1 (6 hours)
|
73.8 Beats per minute
Standard Deviation 7.91
|
65.7 Beats per minute
Standard Deviation 8.45
|
67.1 Beats per minute
Standard Deviation 6.02
|
72.7 Beats per minute
Standard Deviation 7.26
|
63.0 Beats per minute
Standard Deviation 6.23
|
76.3 Beats per minute
Standard Deviation 6.06
|
62.0 Beats per minute
Standard Deviation 11.51
|
|
Heart Rate at Baseline and Times Post Dose
Day 1 (8 hours)
|
67.7 Beats per minute
Standard Deviation 7.2
|
64.0 Beats per minute
Standard Deviation 9.0
|
63.5 Beats per minute
Standard Deviation 6.8
|
68.7 Beats per minute
Standard Deviation 5.2
|
59.7 Beats per minute
Standard Deviation 6.2
|
73.5 Beats per minute
Standard Deviation 12.1
|
62.3 Beats per minute
Standard Deviation 11.2
|
|
Heart Rate at Baseline and Times Post Dose
Day 1 (12 hours)
|
73.2 Beats per minute
Standard Deviation 6.6
|
65.7 Beats per minute
Standard Deviation 10.2
|
63.8 Beats per minute
Standard Deviation 6.8
|
66.5 Beats per minute
Standard Deviation 6.3
|
61.7 Beats per minute
Standard Deviation 8.3
|
74.8 Beats per minute
Standard Deviation 9.9
|
60.7 Beats per minute
Standard Deviation 10.0
|
|
Heart Rate at Baseline and Times Post Dose
Day 2 (24 hours)
|
68.3 Beats per minute
Standard Deviation 7.1
|
62.5 Beats per minute
Standard Deviation 8.5
|
61.8 Beats per minute
Standard Deviation 6.9
|
66.2 Beats per minute
Standard Deviation 6.2
|
57.2 Beats per minute
Standard Deviation 7.2
|
68.0 Beats per minute
Standard Deviation 8.3
|
61.3 Beats per minute
Standard Deviation 8.5
|
|
Heart Rate at Baseline and Times Post Dose
Day 3 (48 hours)
|
66.7 Beats per minute
Standard Deviation 6.89
|
65.7 Beats per minute
Standard Deviation 8.80
|
62.8 Beats per minute
Standard Deviation 5.64
|
67.3 Beats per minute
Standard Deviation 7.87
|
57.7 Beats per minute
Standard Deviation 3.20
|
68.8 Beats per minute
Standard Deviation 7.22
|
62.2 Beats per minute
Standard Deviation 12.73
|
|
Heart Rate at Baseline and Times Post Dose
Day 4 (Day 4 analysis only applicable for arms C,D and E)
|
69.0 Beats per minute
Standard Deviation 9.21
|
66.0 Beats per minute
Standard Deviation 6.66
|
62.8 Beats per minute
Standard Deviation 9.9
|
NA Beats per minute
Standard Deviation NA
Day 4 analysis only applicable for arms C,D and E
|
NA Beats per minute
Standard Deviation NA
Day 4 analysis only applicable for arms C,D and E
|
NA Beats per minute
Standard Deviation NA
Day 4 analysis only applicable for arms C,D and Erts.
|
61.3 Beats per minute
Standard Deviation 7.55
|
PRIMARY outcome
Timeframe: Thru Day 4Population: Safety Analysis Set
PR interval is the time from the beginning of atrial depolarization to the onset of ventricular depolarization. Measured by digital electrocardiograms (ECGs)
Outcome measures
| Measure |
AZD4041 40X mg
n=6 Participants
Single dose oral solution
|
AZD4041 80X mg
n=6 Participants
Single dose oral solution
|
Pooled Placebo
n=12 Participants
Single dose oral solution pooled from 6 cohorts
|
AZD4041 X mg
n=6 Participants
Single dose oral solution
|
AZD4041 3X mg
n=6 Participants
Single dose oral solution
|
AZD4041 9X mg
n=6 Participants
Single dose oral solution
|
AZD4041 80X mg
n=6 Participants
Single dose oral solution
|
|---|---|---|---|---|---|---|---|
|
Aggregate P-R Interval at Baseline and Time Post Dose
Day 1 (0.5 hour)
|
152.0 milliseconds
Standard Deviation 17.18
|
156.0 milliseconds
Standard Deviation 11.03
|
152.3 milliseconds
Standard Deviation 9.18
|
148.5 milliseconds
Standard Deviation 7.53
|
169.2 milliseconds
Standard Deviation 12.77
|
158.5 milliseconds
Standard Deviation 20.63
|
156.3 milliseconds
Standard Deviation 26.88
|
|
Aggregate P-R Interval at Baseline and Time Post Dose
Day 1 (1 hour)
|
151.7 milliseconds
Standard Deviation 16.97
|
159.7 milliseconds
Standard Deviation 12.91
|
151.9 milliseconds
Standard Deviation 7.66
|
151.5 milliseconds
Standard Deviation 9.16
|
170.3 milliseconds
Standard Deviation 12.37
|
157.0 milliseconds
Standard Deviation 21.82
|
158.7 milliseconds
Standard Deviation 25.63
|
|
Aggregate P-R Interval at Baseline and Time Post Dose
Day 1 (1.5 hours)
|
151.0 milliseconds
Standard Deviation 16.76
|
159.2 milliseconds
Standard Deviation 11.30
|
150.9 milliseconds
Standard Deviation 7.54
|
151.0 milliseconds
Standard Deviation 8.97
|
169.2 milliseconds
Standard Deviation 12.27
|
158.8 milliseconds
Standard Deviation 21.66
|
158.5 milliseconds
Standard Deviation 25.27
|
|
Aggregate P-R Interval at Baseline and Time Post Dose
Baseline
|
153.5 milliseconds
Standard Deviation 19.73
|
153.8 milliseconds
Standard Deviation 7.81
|
152.1 milliseconds
Standard Deviation 8.16
|
150.5 milliseconds
Standard Deviation 7.06
|
170.8 milliseconds
Standard Deviation 14.47
|
154.0 milliseconds
Standard Deviation 18.90
|
154.5 milliseconds
Standard Deviation 27.05
|
|
Aggregate P-R Interval at Baseline and Time Post Dose
Day 1 (2 hours)
|
151.2 milliseconds
Standard Deviation 17.02
|
160.5 milliseconds
Standard Deviation 12.18
|
151.8 milliseconds
Standard Deviation 8.67
|
151.2 milliseconds
Standard Deviation 9.00
|
170.8 milliseconds
Standard Deviation 12.75
|
159.5 milliseconds
Standard Deviation 21.06
|
156.8 milliseconds
Standard Deviation 25.87
|
|
Aggregate P-R Interval at Baseline and Time Post Dose
Day 1 (3 hours)
|
150.8 milliseconds
Standard Deviation 15.99
|
156.3 milliseconds
Standard Deviation 14.71
|
153.7 milliseconds
Standard Deviation 9.78
|
151.3 milliseconds
Standard Deviation 7.42
|
166.2 milliseconds
Standard Deviation 10.93
|
158.5 milliseconds
Standard Deviation 22.06
|
158.7 milliseconds
Standard Deviation 28.68
|
|
Aggregate P-R Interval at Baseline and Time Post Dose
Day 1 (4 hours)
|
150.3 milliseconds
Standard Deviation 15.56
|
159.8 milliseconds
Standard Deviation 10.46
|
151.6 milliseconds
Standard Deviation 8.02
|
151.2 milliseconds
Standard Deviation 9.56
|
165.0 milliseconds
Standard Deviation 10.49
|
157.5 milliseconds
Standard Deviation 24.83
|
159.0 milliseconds
Standard Deviation 28.47
|
|
Aggregate P-R Interval at Baseline and Time Post Dose
Day 1 (6 hours)
|
144.2 milliseconds
Standard Deviation 12.77
|
155.0 milliseconds
Standard Deviation 9.12
|
150.4 milliseconds
Standard Deviation 8.75
|
145.5 milliseconds
Standard Deviation 8.83
|
160.7 milliseconds
Standard Deviation 7.23
|
152.7 milliseconds
Standard Deviation 19.75
|
154.7 milliseconds
Standard Deviation 20.27
|
|
Aggregate P-R Interval at Baseline and Time Post Dose
Day 1 (8 hours)
|
146.8 milliseconds
Standard Deviation 13.64
|
155.7 milliseconds
Standard Deviation 9.75
|
150.7 milliseconds
Standard Deviation 7.98
|
146.5 milliseconds
Standard Deviation 7.97
|
162.8 milliseconds
Standard Deviation 8.93
|
155.0 milliseconds
Standard Deviation 20.01
|
153.3 milliseconds
Standard Deviation 23.76
|
|
Aggregate P-R Interval at Baseline and Time Post Dose
Day 1 (12 hours)
|
147.8 milliseconds
Standard Deviation 12.77
|
160.2 milliseconds
Standard Deviation 12.88
|
150.1 milliseconds
Standard Deviation 6.97
|
151.5 milliseconds
Standard Deviation 6.35
|
163.7 milliseconds
Standard Deviation 9.37
|
156.0 milliseconds
Standard Deviation 19.27
|
155.8 milliseconds
Standard Deviation 25.35
|
|
Aggregate P-R Interval at Baseline and Time Post Dose
Day 2 (24 hours)
|
151.3 milliseconds
Standard Deviation 18.78
|
155.8 milliseconds
Standard Deviation 10.23
|
148.7 milliseconds
Standard Deviation 5.52
|
151.5 milliseconds
Standard Deviation 8.67
|
166.5 milliseconds
Standard Deviation 15.40
|
156.3 milliseconds
Standard Deviation 19.50
|
155.5 milliseconds
Standard Deviation 14.21
|
|
Aggregate P-R Interval at Baseline and Time Post Dose
Day 2 (36 hours)
|
151.3 milliseconds
Standard Deviation 17.96
|
156.0 milliseconds
Standard Deviation 8.10
|
151.9 milliseconds
Standard Deviation 6.14
|
152.8 milliseconds
Standard Deviation 9.35
|
163.5 milliseconds
Standard Deviation 12.01
|
161.7 milliseconds
Standard Deviation 20.10
|
158.3 milliseconds
Standard Deviation 26.52
|
|
Aggregate P-R Interval at Baseline and Time Post Dose
Day 3 (48 hours)
|
152.3 milliseconds
Standard Deviation 17.28
|
156.3 milliseconds
Standard Deviation 11.54
|
150.8 milliseconds
Standard Deviation 9.30
|
149.7 milliseconds
Standard Deviation 6.44
|
170.3 milliseconds
Standard Deviation 12.44
|
157.2 milliseconds
Standard Deviation 19.91
|
161.0 milliseconds
Standard Deviation 28.62
|
|
Aggregate P-R Interval at Baseline and Time Post Dose
Day 4 (Day 4 analysis only applicable for arms C,D and E)
|
156.3 milliseconds
Standard Deviation 19.67
|
155.3 milliseconds
Standard Deviation 11.38
|
150.8 milliseconds
Standard Deviation 10.5
|
NA milliseconds
Standard Deviation NA
Day 4 analysis only applicable for arms C,D and E
|
NA milliseconds
Standard Deviation NA
Day 4 analysis only applicable for arms C,D and E
|
NA milliseconds
Standard Deviation NA
Day 4 analysis only applicable for arms C,D and E
|
160.2 milliseconds
Standard Deviation 25.23
|
PRIMARY outcome
Timeframe: Thru Day 4Population: Safety Analysis Set
QRS complex represents the electrical impulse as it spreads through the ventricles and indicates ventricular depolarization. Measured by digital electrocardiograms (ECGs)
Outcome measures
| Measure |
AZD4041 40X mg
n=6 Participants
Single dose oral solution
|
AZD4041 80X mg
n=6 Participants
Single dose oral solution
|
Pooled Placebo
n=12 Participants
Single dose oral solution pooled from 6 cohorts
|
AZD4041 X mg
n=6 Participants
Single dose oral solution
|
AZD4041 3X mg
n=6 Participants
Single dose oral solution
|
AZD4041 9X mg
n=6 Participants
Single dose oral solution
|
AZD4041 80X mg
n=6 Participants
Single dose oral solution
|
|---|---|---|---|---|---|---|---|
|
Aggregate QRS Complex at Baseline and Times Post Dose
Day 4 (Day 4 analysis only applicable for arms C,D and E)
|
87.3 milliseconds
Standard Deviation 7.79
|
86.8 milliseconds
Standard Deviation 8.52
|
35.7 milliseconds
Standard Deviation 6.38
|
NA milliseconds
Standard Deviation NA
Day 4 analysis only applicable for arms C,D and E
|
NA milliseconds
Standard Deviation NA
Day 4 analysis only applicable for arms C,D and E
|
NA milliseconds
Standard Deviation NA
Day 4 analysis only applicable for arms C,D and E
|
89.8 milliseconds
Standard Deviation 7.60
|
|
Aggregate QRS Complex at Baseline and Times Post Dose
Baseline
|
87.7 milliseconds
Standard Deviation 6.02
|
87.7 milliseconds
Standard Deviation 8.50
|
91.1 milliseconds
Standard Deviation 8.67
|
89.5 milliseconds
Standard Deviation 9.33
|
95.3 milliseconds
Standard Deviation 8.82
|
90.2 milliseconds
Standard Deviation 7.57
|
88.0 milliseconds
Standard Deviation 9.53
|
|
Aggregate QRS Complex at Baseline and Times Post Dose
Day 1 (0.5 hour)
|
87.7 milliseconds
Standard Deviation 6.28
|
88.0 milliseconds
Standard Deviation 10.49
|
90.5 milliseconds
Standard Deviation 9.66
|
89.3 milliseconds
Standard Deviation 8.94
|
94.5 milliseconds
Standard Deviation 8.34
|
89.8 milliseconds
Standard Deviation 8.11
|
88.5 milliseconds
Standard Deviation 9.27
|
|
Aggregate QRS Complex at Baseline and Times Post Dose
Day 1 (1 hour)
|
88.5 milliseconds
Standard Deviation 6.09
|
87.5 milliseconds
Standard Deviation 8.92
|
91.7 milliseconds
Standard Deviation 9.40
|
90.9 milliseconds
Standard Deviation 8.41
|
94.3 milliseconds
Standard Deviation 8.52
|
91.3 milliseconds
Standard Deviation 9.44
|
87.7 milliseconds
Standard Deviation 9.24
|
|
Aggregate QRS Complex at Baseline and Times Post Dose
Day 1 (1.5 hours)
|
87.5 milliseconds
Standard Deviation 7.37
|
87.8 milliseconds
Standard Deviation 10.42
|
90.7 milliseconds
Standard Deviation 9.25
|
90.3 milliseconds
Standard Deviation 8.82
|
93.8 milliseconds
Standard Deviation 8.89
|
90.7 milliseconds
Standard Deviation 8.66
|
88.5 milliseconds
Standard Deviation 8.76
|
|
Aggregate QRS Complex at Baseline and Times Post Dose
Day 1 (2 hours)
|
88.5 milliseconds
Standard Deviation 6.02
|
88.0 milliseconds
Standard Deviation 9.67
|
91.3 milliseconds
Standard Deviation 9.18
|
89.7 milliseconds
Standard Deviation 8.73
|
93.7 milliseconds
Standard Deviation 9.73
|
89.5 milliseconds
Standard Deviation 8.62
|
88.7 milliseconds
Standard Deviation 8.50
|
|
Aggregate QRS Complex at Baseline and Times Post Dose
Day 1 (3 hours)
|
88.0 milliseconds
Standard Deviation 7.46
|
88.0 milliseconds
Standard Deviation 11.30
|
91.0 milliseconds
Standard Deviation 9.80
|
89.8 milliseconds
Standard Deviation 8.66
|
94.0 milliseconds
Standard Deviation 8.37
|
90.3 milliseconds
Standard Deviation 7.79
|
89.5 milliseconds
Standard Deviation 8.92
|
|
Aggregate QRS Complex at Baseline and Times Post Dose
Day 1 (4 hours)
|
88.3 milliseconds
Standard Deviation 6.62
|
88.5 milliseconds
Standard Deviation 10.41
|
91.1 milliseconds
Standard Deviation 9.54
|
89.7 milliseconds
Standard Deviation 8.31
|
93.5 milliseconds
Standard Deviation 8.09
|
91.0 milliseconds
Standard Deviation 9.08
|
89.2 milliseconds
Standard Deviation 7.83
|
|
Aggregate QRS Complex at Baseline and Times Post Dose
Day 1 (6 hours)
|
84.8 milliseconds
Standard Deviation 7.47
|
88.3 milliseconds
Standard Deviation 11.25
|
90.3 milliseconds
Standard Deviation 8.97
|
89.3 milliseconds
Standard Deviation 8.07
|
92.0 milliseconds
Standard Deviation 10.18
|
90.5 milliseconds
Standard Deviation 10.01
|
85.0 milliseconds
Standard Deviation 10.04
|
|
Aggregate QRS Complex at Baseline and Times Post Dose
Day 1 (8 hours)
|
86.7 milliseconds
Standard Deviation 7.03
|
87.7 milliseconds
Standard Deviation 11.62
|
90.3 milliseconds
Standard Deviation 9.00
|
88.7 milliseconds
Standard Deviation 9.20
|
92.0 milliseconds
Standard Deviation 9.72
|
89.3 milliseconds
Standard Deviation 9.85
|
87.7 milliseconds
Standard Deviation 8.52
|
|
Aggregate QRS Complex at Baseline and Times Post Dose
Day 1 (12 hours)
|
87.2 milliseconds
Standard Deviation 8.26
|
89.2 milliseconds
Standard Deviation 9.93
|
90.8 milliseconds
Standard Deviation 9.30
|
89.7 milliseconds
Standard Deviation 8.96
|
92.2 milliseconds
Standard Deviation 10.78
|
89.8 milliseconds
Standard Deviation 9.83
|
89.8 milliseconds
Standard Deviation 8.93
|
|
Aggregate QRS Complex at Baseline and Times Post Dose
Day 2 (24 hours)
|
85.7 milliseconds
Standard Deviation 6.56
|
87.8 milliseconds
Standard Deviation 9.50
|
90.4 milliseconds
Standard Deviation 8.53
|
88.7 milliseconds
Standard Deviation 7.34
|
94.0 milliseconds
Standard Deviation 8.60
|
89.8 milliseconds
Standard Deviation 8.73
|
86.5 milliseconds
Standard Deviation 9.54
|
|
Aggregate QRS Complex at Baseline and Times Post Dose
Day 2 (36 hours)
|
87.2 milliseconds
Standard Deviation 8.13
|
37.7 milliseconds
Standard Deviation 7.74
|
90.2 milliseconds
Standard Deviation 10.08
|
89.8 milliseconds
Standard Deviation 8.98
|
91.5 milliseconds
Standard Deviation 8.98
|
91.3 milliseconds
Standard Deviation 9.18
|
80.0 milliseconds
Standard Deviation 8.12
|
|
Aggregate QRS Complex at Baseline and Times Post Dose
Day 3 (48 hours)
|
86.8 milliseconds
Standard Deviation 7.17
|
86.0 milliseconds
Standard Deviation 7.87
|
88.6 milliseconds
Standard Deviation 8.99
|
88.0 milliseconds
Standard Deviation 8.46
|
93.2 milliseconds
Standard Deviation 8.42
|
90.2 milliseconds
Standard Deviation 8.38
|
89.7 milliseconds
Standard Deviation 8.50
|
PRIMARY outcome
Timeframe: Thru Day 4Population: Safety Analysis Set
The QT interval is measured from the beginning of the QRS complex to the end of the T wave and primarily represents the return of stimulated ventricles to their resting state (ventricular repolarization). Measured by digital electrocardiograms (ECGs)
Outcome measures
| Measure |
AZD4041 40X mg
n=6 Participants
Single dose oral solution
|
AZD4041 80X mg
n=6 Participants
Single dose oral solution
|
Pooled Placebo
n=12 Participants
Single dose oral solution pooled from 6 cohorts
|
AZD4041 X mg
n=6 Participants
Single dose oral solution
|
AZD4041 3X mg
n=6 Participants
Single dose oral solution
|
AZD4041 9X mg
n=6 Participants
Single dose oral solution
|
AZD4041 80X mg
n=6 Participants
Single dose oral solution
|
|---|---|---|---|---|---|---|---|
|
Aggregate QT Interval at Baseline and Times Post Dose
Baseline
|
366.3 milliseconds
Standard Deviation 17.66
|
389.2 milliseconds
Standard Deviation 10.21
|
382.5 milliseconds
Standard Deviation 29.29
|
377.8 milliseconds
Standard Deviation 21.61
|
389.5 milliseconds
Standard Deviation 27.27
|
359.2 milliseconds
Standard Deviation 13.50
|
402.2 milliseconds
Standard Deviation 29.91
|
|
Aggregate QT Interval at Baseline and Times Post Dose
Day 1 (0.5 hour)
|
363.0 milliseconds
Standard Deviation 11.76
|
396.3 milliseconds
Standard Deviation 7.26
|
384.5 milliseconds
Standard Deviation 31.22
|
374.8 milliseconds
Standard Deviation 18.88
|
379.8 milliseconds
Standard Deviation 22.42
|
357.0 milliseconds
Standard Deviation 13.89
|
405.3 milliseconds
Standard Deviation 30.58
|
|
Aggregate QT Interval at Baseline and Times Post Dose
Day 1 (1 hour)
|
373.2 milliseconds
Standard Deviation 16.09
|
404.3 milliseconds
Standard Deviation 7.23
|
389.9 milliseconds
Standard Deviation 31.50
|
380.8 milliseconds
Standard Deviation 19.08
|
381.5 milliseconds
Standard Deviation 24.83
|
362.5 milliseconds
Standard Deviation 16.63
|
410.5 milliseconds
Standard Deviation 30.07
|
|
Aggregate QT Interval at Baseline and Times Post Dose
Day 1 (1.5 hours)
|
374.5 milliseconds
Standard Deviation 12.77
|
406.5 milliseconds
Standard Deviation 15.90
|
390.0 milliseconds
Standard Deviation 30.11
|
388.7 milliseconds
Standard Deviation 19.94
|
382.5 milliseconds
Standard Deviation 24.70
|
364.2 milliseconds
Standard Deviation 15.77
|
413.8 milliseconds
Standard Deviation 34.60
|
|
Aggregate QT Interval at Baseline and Times Post Dose
Day 1 (2 hours)
|
377.2 milliseconds
Standard Deviation 14.55
|
411.0 milliseconds
Standard Deviation 9.36
|
391.8 milliseconds
Standard Deviation 28.72
|
383.5 milliseconds
Standard Deviation 20.52
|
383.8 milliseconds
Standard Deviation 25.19
|
362.3 milliseconds
Standard Deviation 17.60
|
417.0 milliseconds
Standard Deviation 31.28
|
|
Aggregate QT Interval at Baseline and Times Post Dose
Day 1 (3 hours)
|
376.7 milliseconds
Standard Deviation 16.60
|
405.8 milliseconds
Standard Deviation 12.50
|
390.6 milliseconds
Standard Deviation 30.40
|
382.0 milliseconds
Standard Deviation 21.14
|
380.3 milliseconds
Standard Deviation 18.36
|
363.2 milliseconds
Standard Deviation 13.32
|
413.0 milliseconds
Standard Deviation 31.93
|
|
Aggregate QT Interval at Baseline and Times Post Dose
Day 1 (4 hours)
|
374.3 milliseconds
Standard Deviation 21.40
|
408.3 milliseconds
Standard Deviation 11.86
|
391.8 milliseconds
Standard Deviation 30.12
|
384.8 milliseconds
Standard Deviation 17.95
|
381.2 milliseconds
Standard Deviation 21.98
|
367.7 milliseconds
Standard Deviation 16.17
|
415.8 milliseconds
Standard Deviation 32.68
|
|
Aggregate QT Interval at Baseline and Times Post Dose
Day 1 (6 hours)
|
345.0 milliseconds
Standard Deviation 21.95
|
386.2 milliseconds
Standard Deviation 13.23
|
369.3 milliseconds
Standard Deviation 24.74
|
356.5 milliseconds
Standard Deviation 21.50
|
364.2 milliseconds
Standard Deviation 17.93
|
346.0 milliseconds
Standard Deviation 13.25
|
387.0 milliseconds
Standard Deviation 29.05
|
|
Aggregate QT Interval at Baseline and Times Post Dose
Day 1 (8 hours)
|
359.7 milliseconds
Standard Deviation 20.20
|
391.0 milliseconds
Standard Deviation 15.94
|
377.9 milliseconds
Standard Deviation 26.52
|
363.0 milliseconds
Standard Deviation 12.43
|
371.0 milliseconds
Standard Deviation 26.60
|
349.0 milliseconds
Standard Deviation 14.60
|
391.8 milliseconds
Standard Deviation 36.66
|
|
Aggregate QT Interval at Baseline and Times Post Dose
Day 1 (12 hours)
|
356.5 milliseconds
Standard Deviation 23.67
|
389.7 milliseconds
Standard Deviation 13.22
|
377.7 milliseconds
Standard Deviation 27.94
|
371.7 milliseconds
Standard Deviation 13.85
|
367.8 milliseconds
Standard Deviation 29.36
|
350.3 milliseconds
Standard Deviation 10.41
|
399.8 milliseconds
Standard Deviation 34.52
|
|
Aggregate QT Interval at Baseline and Times Post Dose
Day 2 (24 hours)
|
358.0 milliseconds
Standard Deviation 19.71
|
396.2 milliseconds
Standard Deviation 20.59
|
380.4 milliseconds
Standard Deviation 22.44
|
370.2 milliseconds
Standard Deviation 20.31
|
374.3 milliseconds
Standard Deviation 24.06
|
359.0 milliseconds
Standard Deviation 15.74
|
400.8 milliseconds
Standard Deviation 27.33
|
|
Aggregate QT Interval at Baseline and Times Post Dose
Day 2 (36 hours)
|
357.0 milliseconds
Standard Deviation 21.25
|
390.8 milliseconds
Standard Deviation 20.13
|
375.2 milliseconds
Standard Deviation 28.50
|
373.2 milliseconds
Standard Deviation 13.42
|
363.8 milliseconds
Standard Deviation 15.88
|
358.5 milliseconds
Standard Deviation 13.28
|
399.2 milliseconds
Standard Deviation 30.42
|
|
Aggregate QT Interval at Baseline and Times Post Dose
Day 3 (48 hours)
|
366.3 milliseconds
Standard Deviation 17.81
|
391.7 milliseconds
Standard Deviation 16.77
|
377.8 milliseconds
Standard Deviation 23.95
|
266.0 milliseconds
Standard Deviation 19.05
|
274.8 milliseconds
Standard Deviation 21.45
|
357.8 milliseconds
Standard Deviation 16.20
|
402.7 milliseconds
Standard Deviation 36.53
|
|
Aggregate QT Interval at Baseline and Times Post Dose
Day 4 (Day 4 analysis only applicable for arms C,D and E)
|
357.8 milliseconds
Standard Deviation 21.15
|
392.2 milliseconds
Standard Deviation 23.99
|
379.5 milliseconds
Standard Deviation 40.02
|
NA milliseconds
Standard Deviation NA
Day 4 analysis only applicable for arms C,D and E
|
NA milliseconds
Standard Deviation NA
Day 4 analysis only applicable for arms C,D and E
|
NA milliseconds
Standard Deviation NA
Day 4 analysis only applicable for arms C,D and E
|
404.7 milliseconds
Standard Deviation 30.59
|
PRIMARY outcome
Timeframe: Thru Day 4Population: Safety Analysis Set
The QTcF if the QT interval corrected for heart rate using Fridercia's formula. Measured by digital electrocardiograms (ECGs)
Outcome measures
| Measure |
AZD4041 40X mg
n=6 Participants
Single dose oral solution
|
AZD4041 80X mg
n=6 Participants
Single dose oral solution
|
Pooled Placebo
n=12 Participants
Single dose oral solution pooled from 6 cohorts
|
AZD4041 X mg
n=6 Participants
Single dose oral solution
|
AZD4041 3X mg
n=6 Participants
Single dose oral solution
|
AZD4041 9X mg
n=6 Participants
Single dose oral solution
|
AZD4041 80X mg
n=6 Participants
Single dose oral solution
|
|---|---|---|---|---|---|---|---|
|
Aggregate QTcF Interval and Times Post Dose
Day 1 (6 hours)
|
369.0 milliseconds
Standard Deviation 17.73
|
396.7 milliseconds
Standard Deviation 13.47
|
382.8 milliseconds
Standard Deviation 20.70
|
379.3 milliseconds
Standard Deviation 21.29
|
369.7 milliseconds
Standard Deviation 17.74
|
374.7 milliseconds
Standard Deviation 16.39
|
388.8 milliseconds
Standard Deviation 13.82
|
|
Aggregate QTcF Interval and Times Post Dose
Baseline
|
374.7 milliseconds
Standard Deviation 21.39
|
402.0 milliseconds
Standard Deviation 17.34
|
382.9 milliseconds
Standard Deviation 23.45
|
383.3 milliseconds
Standard Deviation 20.29
|
374.8 milliseconds
Standard Deviation 23.63
|
372.8 milliseconds
Standard Deviation 15.41
|
404.7 milliseconds
Standard Deviation 18.98
|
|
Aggregate QTcF Interval and Times Post Dose
Day 1 (0.5 hour)
|
373.2 milliseconds
Standard Deviation 20.37
|
398.7 milliseconds
Standard Deviation 14.50
|
381.0 milliseconds
Standard Deviation 38.33
|
382.7 milliseconds
Standard Deviation 18.5
|
370.0 milliseconds
Standard Deviation 21.96
|
371.0 milliseconds
Standard Deviation 17.85
|
398.0 milliseconds
Standard Deviation 17.79
|
|
Aggregate QTcF Interval and Times Post Dose
Day 1 (1 hour)
|
378.7 milliseconds
Standard Deviation 20.78
|
405.3 milliseconds
Standard Deviation 18.95
|
387.0 milliseconds
Standard Deviation 38.04
|
385.3 milliseconds
Standard Deviation 20.61
|
372.7 milliseconds
Standard Deviation 23.57
|
375.0 milliseconds
Standard Deviation 19.31
|
403.3 milliseconds
Standard Deviation 22.06
|
|
Aggregate QTcF Interval and Times Post Dose
Day 1 (1.5 hours)
|
380.5 milliseconds
Standard Deviation 20.32
|
409.3 milliseconds
Standard Deviation 20.03
|
385.9 milliseconds
Standard Deviation 26.62
|
393.7 milliseconds
Standard Deviation 23.39
|
374.0 milliseconds
Standard Deviation 25.20
|
375.2 milliseconds
Standard Deviation 18.32
|
405.8 milliseconds
Standard Deviation 19.46
|
|
Aggregate QTcF Interval and Times Post Dose
Day 1 (2 hours)
|
380.0 milliseconds
Standard Deviation 21.35
|
411.7 milliseconds
Standard Deviation 18.08
|
386.6 milliseconds
Standard Deviation 25.90
|
389.8 milliseconds
Standard Deviation 22.93
|
374.0 milliseconds
Standard Deviation 26.27
|
375.7 milliseconds
Standard Deviation 18.48
|
409.7 milliseconds
Standard Deviation 22.05
|
|
Aggregate QTcF Interval and Times Post Dose
Day 1 (3 hours)
|
381.5 milliseconds
Standard Deviation 21.78
|
411.8 milliseconds
Standard Deviation 16.80
|
385.6 milliseconds
Standard Deviation 26.61
|
392.8 milliseconds
Standard Deviation 23.78
|
373.0 milliseconds
Standard Deviation 23.44
|
376.3 milliseconds
Standard Deviation 18.45
|
407.2 milliseconds
Standard Deviation 19.65
|
|
Aggregate QTcF Interval and Times Post Dose
Day 1 (4 hours)
|
382.3 milliseconds
Standard Deviation 19.76
|
409.7 milliseconds
Standard Deviation 16.78
|
388.0 milliseconds
Standard Deviation 24.80
|
394.2 milliseconds
Standard Deviation 23.27
|
373.2 milliseconds
Standard Deviation 23.02
|
379.5 milliseconds
Standard Deviation 17.21
|
407.8 milliseconds
Standard Deviation 21.86
|
|
Aggregate QTcF Interval and Times Post Dose
Day 1 (8 hours)
|
373.7 milliseconds
Standard Deviation 16.23
|
398.5 milliseconds
Standard Deviation 19.93
|
383.9 milliseconds
Standard Deviation 20.34
|
380.0 milliseconds
Standard Deviation 17.52
|
369.8 milliseconds
Standard Deviation 22.20
|
371.8 milliseconds
Standard Deviation 15.25
|
393.7 milliseconds
Standard Deviation 16.23
|
|
Aggregate QTcF Interval and Times Post Dose
Day 1 (12 hours)
|
380.0 milliseconds
Standard Deviation 20.31
|
400.5 milliseconds
Standard Deviation 9.59
|
384.5 milliseconds
Standard Deviation 23.77
|
384.2 milliseconds
Standard Deviation 14.47
|
369.7 milliseconds
Standard Deviation 23.24
|
376.2 milliseconds
Standard Deviation 12.83
|
399.0 milliseconds
Standard Deviation 17.05
|
|
Aggregate QTcF Interval and Times Post Dose
Day 2 (24 hours)
|
373.3 milliseconds
Standard Deviation 19.73
|
400.8 milliseconds
Standard Deviation 19.16
|
382.2 milliseconds
Standard Deviation 21.46
|
381.7 milliseconds
Standard Deviation 20.07
|
367.3 milliseconds
Standard Deviation 20.22
|
373.8 milliseconds
Standard Deviation 18.37
|
402.3 milliseconds
Standard Deviation 20.56
|
|
Aggregate QTcF Interval and Times Post Dose
Day 2 (36 hours)
|
379.8 milliseconds
Standard Deviation 17.62
|
406.3 milliseconds
Standard Deviation 22.34
|
384.3 milliseconds
Standard Deviation 21.21
|
383.3 milliseconds
Standard Deviation 17.85
|
366.0 milliseconds
Standard Deviation 14.38
|
378.3 milliseconds
Standard Deviation 14.32
|
399.2 milliseconds
Standard Deviation 9.72
|
|
Aggregate QTcF Interval and Times Post Dose
Day 3 (48 hours)
|
379.0 milliseconds
Standard Deviation 18.87
|
402.7 milliseconds
Standard Deviation 17.39
|
383.0 milliseconds
Standard Deviation 20.91
|
379.5 milliseconds
Standard Deviation 17.21
|
269.3 milliseconds
Standard Deviation 18.54
|
373.8 milliseconds
Standard Deviation 16.39
|
404.3 milliseconds
Standard Deviation 13.65
|
|
Aggregate QTcF Interval and Times Post Dose
Day 4 (Day 4 analysis only applicable for arms C,D and E)
|
374.2 milliseconds
Standard Deviation 16.77
|
403.8 milliseconds
Standard Deviation 20.09
|
383.0 milliseconds
Standard Deviation 27.25
|
NA milliseconds
Standard Deviation NA
Day 4 analysis only applicable for arms C,D and E
|
NA milliseconds
Standard Deviation NA
Day 4 analysis only applicable for arms C,D and E
|
NA milliseconds
Standard Deviation NA
Day 4 analysis only applicable for arms C,D and E cohorts
|
406.0 milliseconds
Standard Deviation 17.60
|
PRIMARY outcome
Timeframe: Thru Day 4Population: Safety Analysis Set
The RR interval the time elapsed between two successive R waves of the QRS signal on the electrocardiogram. Measured by digital electrocardiograms (ECGs)
Outcome measures
| Measure |
AZD4041 40X mg
n=6 Participants
Single dose oral solution
|
AZD4041 80X mg
n=6 Participants
Single dose oral solution
|
Pooled Placebo
n=12 Participants
Single dose oral solution pooled from 6 cohorts
|
AZD4041 X mg
n=6 Participants
Single dose oral solution
|
AZD4041 3X mg
n=6 Participants
Single dose oral solution
|
AZD4041 9X mg
n=6 Participants
Single dose oral solution
|
AZD4041 80X mg
n=6 Participants
Single dose oral solution
|
|---|---|---|---|---|---|---|---|
|
Aggregate RR Interval at Baseline and Times Post Dose
Baseline
|
939.0 milliseconds
Standard Deviation 70.03
|
913.0 milliseconds
Standard Deviation 85.26
|
998.9 milliseconds
Standard Deviation 94.86
|
957.5 milliseconds
Standard Deviation 55.03
|
1126.0 milliseconds
Standard Deviation 123.29
|
896.5 milliseconds
Standard Deviation 76.66
|
985.0 milliseconds
Standard Deviation 127.74
|
|
Aggregate RR Interval at Baseline and Times Post Dose
Day 1 (0.5 hour)
|
927.0 milliseconds
Standard Deviation 90.52
|
988.2 milliseconds
Standard Deviation 111.95
|
1029.6 milliseconds
Standard Deviation 78.39
|
942.0 milliseconds
Standard Deviation 62.03
|
1086.3 milliseconds
Standard Deviation 105.03
|
898.7 milliseconds
Standard Deviation 124.48
|
1059.8 milliseconds
Standard Deviation 153.49
|
|
Aggregate RR Interval at Baseline and Times Post Dose
Day 1 (1 hour)
|
962.0 milliseconds
Standard Deviation 74.11
|
1003.5 milliseconds
Standard Deviation 139.04
|
1023.9 milliseconds
Standard Deviation 81.90
|
968.3 milliseconds
Standard Deviation 89.63
|
1075.8 milliseconds
Standard Deviation 105.83
|
912.0 milliseconds
Standard Deviation 132.25
|
1057.8 milliseconds
Standard Deviation 138.05
|
|
Aggregate RR Interval at Baseline and Times Post Dose
Day 1 (1.5 hours)
|
960.7 milliseconds
Standard Deviation 89.40
|
989.7 milliseconds
Standard Deviation 144.62
|
1035.2 milliseconds
Standard Deviation 95.40
|
965.5 milliseconds
Standard Deviation 84.72
|
1074.2 milliseconds
Standard Deviation 95.98
|
922.3 milliseconds
Standard Deviation 134.42
|
1071.5 milliseconds
Standard Deviation 207.00
|
|
Aggregate RR Interval at Baseline and Times Post Dose
Day 1 (2 hours)
|
983.3 milliseconds
Standard Deviation 99.76
|
1003.5 milliseconds
Standard Deviation 141.24
|
1043.1 milliseconds
Standard Deviation 81.48
|
958.0 milliseconds
Standard Deviation 107.71
|
1089.3 milliseconds
Standard Deviation 148.54
|
904.7 milliseconds
Standard Deviation 121.65
|
1059.3 milliseconds
Standard Deviation 152.01
|
|
Aggregate RR Interval at Baseline and Times Post Dose
Day 1 (3 hours)
|
966.5 milliseconds
Standard Deviation 85.55
|
965.2 milliseconds
Standard Deviation 123.68
|
1041.4 milliseconds
Standard Deviation 100.88
|
925.2 milliseconds
Standard Deviation 94.41
|
1066.3 milliseconds
Standard Deviation 96.37
|
905.0 milliseconds
Standard Deviation 101.31
|
1048.8 milliseconds
Standard Deviation 158.48
|
|
Aggregate RR Interval at Baseline and Times Post Dose
Day 1 (4 hours)
|
941.8 milliseconds
Standard Deviation 71.97
|
998.7 milliseconds
Standard Deviation 145.89
|
1030.5 milliseconds
Standard Deviation 101.07
|
938.3 milliseconds
Standard Deviation 102.44
|
1068.2 milliseconds
Standard Deviation 78.58
|
916.2 milliseconds
Standard Deviation 112.82
|
1063.7 milliseconds
Standard Deviation 145.71
|
|
Aggregate RR Interval at Baseline and Times Post Dose
Day 1 (6 hours)
|
819.2 milliseconds
Standard Deviation 86.55
|
929.7 milliseconds
Standard Deviation 128.82
|
900.5 milliseconds
Standard Deviation 80.31
|
832.7 milliseconds
Standard Deviation 83.65
|
959.5 milliseconds
Standard Deviation 74.07
|
790.0 milliseconds
Standard Deviation 63.33
|
996.2 milliseconds
Standard Deviation 184.44
|
|
Aggregate RR Interval at Baseline and Times Post Dose
Day 1 (8 hours)
|
894.8 milliseconds
Standard Deviation 92.50
|
955.0 milliseconds
Standard Deviation 139.11
|
955.1 milliseconds
Standard Deviation 100.17
|
875.8 milliseconds
Standard Deviation 67.69
|
1012.3 milliseconds
Standard Deviation 101.19
|
837.0 milliseconds
Standard Deviation 147.36
|
990.5 milliseconds
Standard Deviation 178.05
|
|
Aggregate RR Interval at Baseline and Times Post Dose
Day 1 (12 hours)
|
826.3 milliseconds
Standard Deviation 76.49
|
929.8 milliseconds
Standard Deviation 147.80
|
950.9 milliseconds
Standard Deviation 102.54
|
909.2 milliseconds
Standard Deviation 85.41
|
899.0 milliseconds
Standard Deviation 129.62
|
813.8 milliseconds
Standard Deviation 144.25
|
1012.3 milliseconds
Standard Deviation 172.32
|
|
Aggregate RR Interval at Baseline and Times Post Dose
Day 2 (24 hours)
|
884.7 milliseconds
Standard Deviation 94.73
|
973.8 milliseconds
Standard Deviation 139.99
|
990.7 milliseconds
Standard Deviation 112.51
|
915.3 milliseconds
Standard Deviation 90.73
|
1064.0 milliseconds
Standard Deviation 139.41
|
891.3 milliseconds
Standard Deviation 103.62
|
994.7 milliseconds
Standard Deviation 141.06
|
|
Aggregate RR Interval at Baseline and Times Post Dose
Day 2 (36 hours)
|
836.0 milliseconds
Standard Deviation 110.22
|
897.8 milliseconds
Standard Deviation 125.72
|
931.5 milliseconds
Standard Deviation 102.06
|
930.3 milliseconds
Standard Deviation 130.67
|
985.0 milliseconds
Standard Deviation 78.92
|
856.7 milliseconds
Standard Deviation 111.45
|
1004.0 milliseconds
Standard Deviation 170.62
|
|
Aggregate RR Interval at Baseline and Times Post Dose
Day 3 (48 hours)
|
906.8 milliseconds
Standard Deviation 88.49
|
928.2 milliseconds
Standard Deviation 134.76
|
960.9 milliseconds
Standard Deviation 81.90
|
900.3 milliseconds
Standard Deviation 101.70
|
1044.5 milliseconds
Standard Deviation 57.48
|
881.5 milliseconds
Standard Deviation 95.33
|
996.0 milliseconds
Standard Deviation 196.50
|
|
Aggregate RR Interval at Baseline and Times Post Dose
Day 4 (Day 4 analysis only applicable for arms C,D and E)
|
879.0 milliseconds
Standard Deviation 106.47
|
918.3 milliseconds
Standard Deviation 94.50
|
973.3 milliseconds
Standard Deviation 142.46
|
NA milliseconds
Standard Deviation NA
Day 4 analysis only applicable for arms C,D and E
|
NA milliseconds
Standard Deviation NA
Day 4 analysis only applicable for arms C,D and E
|
NA milliseconds
Standard Deviation NA
Day 4 analysis only applicable for arms C,D and E
|
991.7 milliseconds
Standard Deviation 118.28
|
PRIMARY outcome
Timeframe: Thru Day 4Population: Safety Analysis Set (Performed only in males recruited after protocol amendment)
Number of participants with abnormal testosterone levels test results, considered clinically significant or reported as a treatment-emergent adverse event by the investigator
Outcome measures
| Measure |
AZD4041 40X mg
n=1 Participants
Single dose oral solution
|
AZD4041 80X mg
n=1 Participants
Single dose oral solution
|
Pooled Placebo
n=4 Participants
Single dose oral solution pooled from 6 cohorts
|
AZD4041 X mg
Single dose oral solution
|
AZD4041 3X mg
Single dose oral solution
|
AZD4041 9X mg
Single dose oral solution
|
AZD4041 80X mg
n=2 Participants
Single dose oral solution
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Abnormal Testosterone Test Results
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Thru Day 4Population: Safety Analysis Set (Performed only in males recruited after protocol amendment)
Number of participants with abnormal luteinizing hormone (LH) levels test results, considered clinically significant or reported as a treatment-emergent adverse event by the investigator
Outcome measures
| Measure |
AZD4041 40X mg
Single dose oral solution
|
AZD4041 80X mg
n=1 Participants
Single dose oral solution
|
Pooled Placebo
n=4 Participants
Single dose oral solution pooled from 6 cohorts
|
AZD4041 X mg
Single dose oral solution
|
AZD4041 3X mg
Single dose oral solution
|
AZD4041 9X mg
Single dose oral solution
|
AZD4041 80X mg
n=2 Participants
Single dose oral solution
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Abnormal Luteinizing Hormone Test Results
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Thru Day 4Population: Safety Analysis Set (Performed only in males recruited after protocol amendment)
Number of participants with abnormal follicle stimulating hormone (FSH) levels test results, considered clinically significant or reported as a treatment-emergent adverse event by the investigator
Outcome measures
| Measure |
AZD4041 40X mg
Single dose oral solution
|
AZD4041 80X mg
n=1 Participants
Single dose oral solution
|
Pooled Placebo
n=4 Participants
Single dose oral solution pooled from 6 cohorts
|
AZD4041 X mg
Single dose oral solution
|
AZD4041 3X mg
Single dose oral solution
|
AZD4041 9X mg
Single dose oral solution
|
AZD4041 80X mg
n=2 Participants
Single dose oral solution
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Abnormal Follicle Stimulating Hormone Test Results
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Thru Day 4Population: Safety Analysis Set (Performed only in males recruited after protocol amendment)
Number of participants with abnormal Inhibin B levels test results, considered clinically significant or reported as a treatment-emergent adverse event by the investigator
Outcome measures
| Measure |
AZD4041 40X mg
n=1 Participants
Single dose oral solution
|
AZD4041 80X mg
n=1 Participants
Single dose oral solution
|
Pooled Placebo
n=4 Participants
Single dose oral solution pooled from 6 cohorts
|
AZD4041 X mg
Single dose oral solution
|
AZD4041 3X mg
Single dose oral solution
|
AZD4041 9X mg
Single dose oral solution
|
AZD4041 80X mg
n=2 Participants
Single dose oral solution
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Abnormal Inhibin B Test Results
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Thru Day 4Population: Pharmacokinetic Analysis Set
Maximum (peak) plasma concentration of AZD4041
Outcome measures
| Measure |
AZD4041 40X mg
n=6 Participants
Single dose oral solution
|
AZD4041 80X mg
n=6 Participants
Single dose oral solution
|
Pooled Placebo
n=6 Participants
Single dose oral solution pooled from 6 cohorts
|
AZD4041 X mg
n=6 Participants
Single dose oral solution
|
AZD4041 3X mg
n=6 Participants
Single dose oral solution
|
AZD4041 9X mg
n=6 Participants
Single dose oral solution
|
AZD4041 80X mg
Single dose oral solution
|
|---|---|---|---|---|---|---|---|
|
Cmax of AZD4041
|
620 ng/mL
Geometric Coefficient of Variation 25.9
|
1060 ng/mL
Geometric Coefficient of Variation 26.0
|
14.7 ng/mL
Geometric Coefficient of Variation 15.0
|
44.6 ng/mL
Geometric Coefficient of Variation 37.9
|
154 ng/mL
Geometric Coefficient of Variation 24.7
|
382 ng/mL
Geometric Coefficient of Variation 21.2
|
—
|
SECONDARY outcome
Timeframe: Thru Day 4Population: Pharmacokinetic Analysis Set
Time to reach maximum (peak) plasma concentration of AZD4041
Outcome measures
| Measure |
AZD4041 40X mg
n=6 Participants
Single dose oral solution
|
AZD4041 80X mg
n=6 Participants
Single dose oral solution
|
Pooled Placebo
n=6 Participants
Single dose oral solution pooled from 6 cohorts
|
AZD4041 X mg
n=6 Participants
Single dose oral solution
|
AZD4041 3X mg
n=6 Participants
Single dose oral solution
|
AZD4041 9X mg
n=6 Participants
Single dose oral solution
|
AZD4041 80X mg
Single dose oral solution
|
|---|---|---|---|---|---|---|---|
|
Tmax of AZD4041
|
1.00 hour
Interval 0.25 to 1.55
|
1.00 hour
Interval 0.5 to 2.0
|
0.50 hour
Interval 0.5 to 1.0
|
1.00 hour
Interval 0.5 to 2.02
|
0.50 hour
Interval 0.5 to 0.5
|
1.00 hour
Interval 0.5 to 1.15
|
—
|
SECONDARY outcome
Timeframe: Thru Day 4Population: Pharmacokinetic Analysis Set
Area under the curve of AZD4041 from time 0 to time t (AUC from zero to the last measurable concentration)
Outcome measures
| Measure |
AZD4041 40X mg
n=6 Participants
Single dose oral solution
|
AZD4041 80X mg
n=6 Participants
Single dose oral solution
|
Pooled Placebo
n=6 Participants
Single dose oral solution pooled from 6 cohorts
|
AZD4041 X mg
n=6 Participants
Single dose oral solution
|
AZD4041 3X mg
n=6 Participants
Single dose oral solution
|
AZD4041 9X mg
n=6 Participants
Single dose oral solution
|
AZD4041 80X mg
Single dose oral solution
|
|---|---|---|---|---|---|---|---|
|
AUC0-t
|
8460 ng·hour/mL
Geometric Coefficient of Variation 34.8
|
14400 ng·hour/mL
Geometric Coefficient of Variation 27.4
|
158 ng·hour/mL
Geometric Coefficient of Variation 22.8
|
585 ng·hour/mL
Geometric Coefficient of Variation 49.1
|
1790 ng·hour/mL
Geometric Coefficient of Variation 29.4
|
5510 ng·hour/mL
Geometric Coefficient of Variation 45.6
|
—
|
SECONDARY outcome
Timeframe: Thru Day 4Population: Pharmacokinetic Analysis Set. Note AUC0-inf values were excluded where AUCExtrap was \>20%
Extrapolation of the area under the curve of AZD4041 from zero to infinity
Outcome measures
| Measure |
AZD4041 40X mg
n=6 Participants
Single dose oral solution
|
AZD4041 80X mg
n=5 Participants
Single dose oral solution
|
Pooled Placebo
n=3 Participants
Single dose oral solution pooled from 6 cohorts
|
AZD4041 X mg
n=5 Participants
Single dose oral solution
|
AZD4041 3X mg
n=3 Participants
Single dose oral solution
|
AZD4041 9X mg
n=6 Participants
Single dose oral solution
|
AZD4041 80X mg
Single dose oral solution
|
|---|---|---|---|---|---|---|---|
|
AUC0-inf
|
9270 ng·hour/mL
Geometric Coefficient of Variation 41.0
|
14800 ng·hour/mL
Geometric Coefficient of Variation 31.6
|
192 ng·hour/mL
Geometric Coefficient of Variation 14.7
|
539 ng·hour/mL
Geometric Coefficient of Variation 35.8
|
1660 ng·hour/mL
Geometric Coefficient of Variation 38.9
|
5950 ng·hour/mL
Geometric Coefficient of Variation 52.4
|
—
|
SECONDARY outcome
Timeframe: Thru Day 4Population: Pharmacokinetic Analysis Set.
Terminal half-life of AZD4041
Outcome measures
| Measure |
AZD4041 40X mg
n=6 Participants
Single dose oral solution
|
AZD4041 80X mg
n=6 Participants
Single dose oral solution
|
Pooled Placebo
n=5 Participants
Single dose oral solution pooled from 6 cohorts
|
AZD4041 X mg
n=6 Participants
Single dose oral solution
|
AZD4041 3X mg
n=6 Participants
Single dose oral solution
|
AZD4041 9X mg
n=6 Participants
Single dose oral solution
|
AZD4041 80X mg
Single dose oral solution
|
|---|---|---|---|---|---|---|---|
|
t1/2λz
|
19.8 hour
Geometric Coefficient of Variation 33.3
|
16.0 hour
Geometric Coefficient of Variation 22.8
|
17.9 hour
Geometric Coefficient of Variation 19.0
|
13.0 hour
Geometric Coefficient of Variation 40.5
|
19.9 hour
Geometric Coefficient of Variation 44.7
|
17.9 hour
Geometric Coefficient of Variation 37.9
|
—
|
SECONDARY outcome
Timeframe: Thru Day 4Population: Pharmacokinetic Analysis Set. Note CL/V values were excluded where AUCExtrap was \>20%.
Apparent total clearance of the AZD4041 from plasma
Outcome measures
| Measure |
AZD4041 40X mg
n=6 Participants
Single dose oral solution
|
AZD4041 80X mg
n=5 Participants
Single dose oral solution
|
Pooled Placebo
n=3 Participants
Single dose oral solution pooled from 6 cohorts
|
AZD4041 X mg
n=5 Participants
Single dose oral solution
|
AZD4041 3X mg
n=3 Participants
Single dose oral solution
|
AZD4041 9X mg
n=6 Participants
Single dose oral solution
|
AZD4041 80X mg
Single dose oral solution
|
|---|---|---|---|---|---|---|---|
|
CL/F (Volume/Time)
|
2.16 L/hour
Geometric Coefficient of Variation 41.0
|
2.70 L/hour
Geometric Coefficient of Variation 31.6
|
2.6 L/hour
Geometric Coefficient of Variation 14.7
|
2.8 L/hour
Geometric Coefficient of Variation 35.8
|
2.7 L/hour
Geometric Coefficient of Variation 38.9
|
1.68 L/hour
Geometric Coefficient of Variation 52.4
|
—
|
SECONDARY outcome
Timeframe: Thru Day 4Population: Pharmacokinetic Analysis Set. Note Vss/F values were excluded where AUCExtrap was \>20%.
Apparent volume of distribution of AZD4041 at steady state
Outcome measures
| Measure |
AZD4041 40X mg
n=6 Participants
Single dose oral solution
|
AZD4041 80X mg
n=5 Participants
Single dose oral solution
|
Pooled Placebo
n=3 Participants
Single dose oral solution pooled from 6 cohorts
|
AZD4041 X mg
n=5 Participants
Single dose oral solution
|
AZD4041 3X mg
n=3 Participants
Single dose oral solution
|
AZD4041 9X mg
n=6 Participants
Single dose oral solution
|
AZD4041 80X mg
Single dose oral solution
|
|---|---|---|---|---|---|---|---|
|
Vss/F (Plasma)
|
61.7 L
Geometric Coefficient of Variation 22.1
|
57.2 L
Geometric Coefficient of Variation 24.3
|
68.8 L
Geometric Coefficient of Variation 4.2
|
45.4 L
Geometric Coefficient of Variation 26.2
|
56.0 L
Geometric Coefficient of Variation 22.9
|
43.3 L
Geometric Coefficient of Variation 22.1
|
—
|
Adverse Events
Pooled Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
AZD4041 X mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
AZD4041 3X mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
AZD4041 9X mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
AZD4041 20X mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
AZD4041 40X mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
AZD4041 80X mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Pooled Placebo
n=12 participants at risk
Single dose oral solution pooled from 6 cohorts
|
AZD4041 X mg
n=6 participants at risk
Single dose oral solution
|
AZD4041 3X mg
n=6 participants at risk
Single dose oral solution
|
AZD4041 9X mg
n=6 participants at risk
Single dose oral solution
|
AZD4041 20X mg
n=6 participants at risk
Single dose oral solution
|
AZD4041 40X mg
n=6 participants at risk
Single dose oral solution
|
AZD4041 80X mg
n=6 participants at risk
Single dose oral solution
|
|---|---|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/12 • 6 weeks
|
0.00%
0/6 • 6 weeks
|
0.00%
0/6 • 6 weeks
|
0.00%
0/6 • 6 weeks
|
0.00%
0/6 • 6 weeks
|
16.7%
1/6 • Number of events 1 • 6 weeks
|
16.7%
1/6 • Number of events 1 • 6 weeks
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/12 • 6 weeks
|
0.00%
0/6 • 6 weeks
|
0.00%
0/6 • 6 weeks
|
0.00%
0/6 • 6 weeks
|
16.7%
1/6 • Number of events 1 • 6 weeks
|
16.7%
1/6 • Number of events 1 • 6 weeks
|
0.00%
0/6 • 6 weeks
|
|
Cardiac disorders
Sinus tachycardia
|
8.3%
1/12 • Number of events 1 • 6 weeks
|
0.00%
0/6 • 6 weeks
|
0.00%
0/6 • 6 weeks
|
0.00%
0/6 • 6 weeks
|
0.00%
0/6 • 6 weeks
|
0.00%
0/6 • 6 weeks
|
0.00%
0/6 • 6 weeks
|
|
Gastrointestinal disorders
Abdominal distension
|
8.3%
1/12 • Number of events 1 • 6 weeks
|
0.00%
0/6 • 6 weeks
|
0.00%
0/6 • 6 weeks
|
0.00%
0/6 • 6 weeks
|
0.00%
0/6 • 6 weeks
|
0.00%
0/6 • 6 weeks
|
0.00%
0/6 • 6 weeks
|
|
Gastrointestinal disorders
Infrequent bowel movements
|
8.3%
1/12 • Number of events 1 • 6 weeks
|
0.00%
0/6 • 6 weeks
|
0.00%
0/6 • 6 weeks
|
0.00%
0/6 • 6 weeks
|
0.00%
0/6 • 6 weeks
|
0.00%
0/6 • 6 weeks
|
0.00%
0/6 • 6 weeks
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/12 • 6 weeks
|
0.00%
0/6 • 6 weeks
|
16.7%
1/6 • Number of events 1 • 6 weeks
|
0.00%
0/6 • 6 weeks
|
0.00%
0/6 • 6 weeks
|
0.00%
0/6 • 6 weeks
|
0.00%
0/6 • 6 weeks
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/12 • 6 weeks
|
0.00%
0/6 • 6 weeks
|
16.7%
1/6 • Number of events 1 • 6 weeks
|
0.00%
0/6 • 6 weeks
|
0.00%
0/6 • 6 weeks
|
0.00%
0/6 • 6 weeks
|
0.00%
0/6 • 6 weeks
|
|
General disorders
Medical device site dermatitis
|
8.3%
1/12 • Number of events 1 • 6 weeks
|
0.00%
0/6 • 6 weeks
|
0.00%
0/6 • 6 weeks
|
0.00%
0/6 • 6 weeks
|
0.00%
0/6 • 6 weeks
|
16.7%
1/6 • Number of events 1 • 6 weeks
|
0.00%
0/6 • 6 weeks
|
|
Nervous system disorders
Headache
|
8.3%
1/12 • Number of events 1 • 6 weeks
|
0.00%
0/6 • 6 weeks
|
0.00%
0/6 • 6 weeks
|
16.7%
1/6 • Number of events 1 • 6 weeks
|
0.00%
0/6 • 6 weeks
|
0.00%
0/6 • 6 weeks
|
0.00%
0/6 • 6 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/12 • 6 weeks
|
0.00%
0/6 • 6 weeks
|
0.00%
0/6 • 6 weeks
|
0.00%
0/6 • 6 weeks
|
0.00%
0/6 • 6 weeks
|
16.7%
1/6 • Number of events 1 • 6 weeks
|
0.00%
0/6 • 6 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
8.3%
1/12 • Number of events 1 • 6 weeks
|
0.00%
0/6 • 6 weeks
|
0.00%
0/6 • 6 weeks
|
0.00%
0/6 • 6 weeks
|
0.00%
0/6 • 6 weeks
|
0.00%
0/6 • 6 weeks
|
0.00%
0/6 • 6 weeks
|
|
Psychiatric disorders
Anxiety
|
8.3%
1/12 • Number of events 1 • 6 weeks
|
0.00%
0/6 • 6 weeks
|
0.00%
0/6 • 6 weeks
|
0.00%
0/6 • 6 weeks
|
0.00%
0/6 • 6 weeks
|
0.00%
0/6 • 6 weeks
|
0.00%
0/6 • 6 weeks
|
|
Vascular disorders
Orthostatic hypotension
|
8.3%
1/12 • Number of events 1 • 6 weeks
|
0.00%
0/6 • 6 weeks
|
0.00%
0/6 • 6 weeks
|
0.00%
0/6 • 6 weeks
|
0.00%
0/6 • 6 weeks
|
0.00%
0/6 • 6 weeks
|
0.00%
0/6 • 6 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place