Trial Outcomes & Findings for A Single Ascending Dose Study To Assess The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of AZD9567. (NCT NCT02512575)
NCT ID: NCT02512575
Last Updated: 2018-10-04
Results Overview
Safety and tolerability variables included AEs, vital signs (blood pressure and pulse), ECGs (12-lead ECGs, safety ECGs and telemetry), clinical laboratory safety evaluations (haematology, clinical chemistry \[including osteocalcin\], coagulation, urinalysis \[including 24 hour urine cortisol per day {tU-cortisol}\]) and physical examinations. Note: No clinically relevant findings were noted in clinical laboratory results and vial signs assessments. Hence, none of the laboratory or vital signs findings were reported as AEs.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
72 participants
Primary outcome timeframe
At screening, Day -2, Day -1, Day 1 (at pre-dose; 3 & 12 hours post-dose), Day 2 (24 hours post-dose), Day 3 and follow-up (7 to 10 days post-dose)
Results posted on
2018-10-04
Participant Flow
Phase 1, single-center (Berlin), randomized, single-blind, placebo-controlled study carried on 72 healthy male participants (8 subjects per cohort). In Cohort 1-8, participants were randomized to AZD9567:placebo (6:2). In Cohort 9, participants were randomized to prednisolone:placebo (6:2). Participants received treatment in a fasted state
Screening period (Day -28 to Day -3). For Cohort 7, screening period was up to 21 days
Participant milestones
| Measure |
AZD9567 - 2 mg
In Cohort 1, participants received single dose of AZD8567 2 mg oral suspension in the fasted state
|
AZD9567 - 10 mg
In Cohort 2, participants received single dose of AZD8567 10 mg oral suspension in the fasted state
|
AZD9567 - 20 mg
In Cohort 3, participants received single dose of AZD8567 20 mg oral suspension in the fasted state
|
AZD9567 - 40 mg
In Cohort 4, participants received single dose of AZD8567 40 mg oral suspension in the fasted state
|
AZD9567 - 80 mg
In Cohort 5, participants received single dose of AZD8567 80 mg oral suspension in the fasted state
|
AZD9567 - 100 mg
In Cohort 6, participants received single dose of AZD8567 100 mg oral suspension in the fasted state
|
AZD9567 - 125 mg
In Cohort 7, participants received single dose of AZD8567 125 mg oral suspension in the fasted state
|
AZD9567 - 155 mg
In Cohort 8, participants received single dose of AZD8567 155 mg oral suspension in the fasted state
|
Prednisolone - 60 mg
In Cohort 9, participants received orally single dose of prednisolone 60 mg capsule in the fasted state
|
Pooled Placebo
In Cohort 1-8, participants were randomized to AZD9567:placebo (6:2). In Cohort 9, participants were randomized to prednisolone:placebo (6:2)
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
18
|
|
Overall Study
COMPLETED
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
18
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Single Ascending Dose Study To Assess The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of AZD9567.
Baseline characteristics by cohort
| Measure |
AZD9567 - 2 mg
n=6 Participants
In Cohort 1, participants received single dose of AZD8567 2 mg oral suspension in the fasted state
|
AZD9567 - 10 mg
n=6 Participants
In Cohort 2, participants received single dose of AZD8567 10 mg oral suspension in the fasted state
|
AZD9567 - 20 mg
n=6 Participants
In Cohort 3, participants received single dose of AZD8567 20 mg oral suspension in the fasted state
|
AZD9567 - 40 mg
n=6 Participants
In Cohort 4, participants received single dose of AZD8567 40 mg oral suspension in the fasted state
|
AZD9567 - 80 mg
n=6 Participants
In Cohort 5, participants received single dose of AZD8567 80 mg oral suspension in the fasted state
|
AZD9567 - 100 mg
n=6 Participants
In Cohort 6, participants received single dose of AZD8567 100 mg oral suspension in the fasted state
|
AZD9567 - 125 mg
n=6 Participants
In Cohort 7, participants received single dose of AZD8567 125 mg oral suspension in the fasted state
|
AZD9567 - 155 mg
n=6 Participants
In Cohort 8, participants received single dose of AZD8567 155 mg oral suspension in the fasted state
|
Prednisolone - 60 mg
n=6 Participants
In Cohort 9, participants received orally single dose of prednisolone 60 mg capsule in the fasted state
|
Pooled Placebo
n=18 Participants
In Cohort 1-8, participants were randomized to AZD9567:placebo (6:2). In Cohort 9, participants were randomized to prednisolone:placebo (6:2)
|
Total
n=72 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
Cohort 1-8 AZD9567
|
44 Years
STANDARD_DEVIATION 10 • n=5 Participants
|
35 Years
STANDARD_DEVIATION 14 • n=7 Participants
|
35 Years
STANDARD_DEVIATION 8 • n=5 Participants
|
35 Years
STANDARD_DEVIATION 9 • n=4 Participants
|
38 Years
STANDARD_DEVIATION 12 • n=21 Participants
|
34 Years
STANDARD_DEVIATION 9 • n=8 Participants
|
41 Years
STANDARD_DEVIATION 8 • n=8 Participants
|
32 Years
STANDARD_DEVIATION 8 • n=24 Participants
|
0 Years
STANDARD_DEVIATION 0 • n=42 Participants
|
0 Years
STANDARD_DEVIATION 0 • n=42 Participants
|
37 Years
STANDARD_DEVIATION 10 • n=42 Participants
|
|
Age, Continuous
Cohort 9 Prenisolone
|
0 Years
STANDARD_DEVIATION 0 • n=5 Participants
|
0 Years
STANDARD_DEVIATION 0 • n=7 Participants
|
0 Years
STANDARD_DEVIATION 0 • n=5 Participants
|
0 Years
STANDARD_DEVIATION 0 • n=4 Participants
|
0 Years
STANDARD_DEVIATION 0 • n=21 Participants
|
0 Years
STANDARD_DEVIATION 0 • n=8 Participants
|
0 Years
STANDARD_DEVIATION 0 • n=8 Participants
|
0 Years
STANDARD_DEVIATION 0 • n=24 Participants
|
36 Years
STANDARD_DEVIATION 9 • n=42 Participants
|
0 Years
STANDARD_DEVIATION 0 • n=42 Participants
|
36 Years
STANDARD_DEVIATION 9 • n=42 Participants
|
|
Age, Continuous
Pooled Placebo
|
0 Years
STANDARD_DEVIATION 0 • n=5 Participants
|
0 Years
STANDARD_DEVIATION 0 • n=7 Participants
|
0 Years
STANDARD_DEVIATION 0 • n=5 Participants
|
0 Years
STANDARD_DEVIATION 0 • n=4 Participants
|
0 Years
STANDARD_DEVIATION 0 • n=21 Participants
|
0 Years
STANDARD_DEVIATION 0 • n=8 Participants
|
0 Years
STANDARD_DEVIATION 0 • n=8 Participants
|
0 Years
STANDARD_DEVIATION 0 • n=24 Participants
|
0 Years
STANDARD_DEVIATION 0 • n=42 Participants
|
37 Years
STANDARD_DEVIATION 11 • n=42 Participants
|
37 Years
STANDARD_DEVIATION 11 • n=42 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
6 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
18 Participants
n=42 Participants
|
72 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: At screening, Day -2, Day -1, Day 1 (at pre-dose; 3 & 12 hours post-dose), Day 2 (24 hours post-dose), Day 3 and follow-up (7 to 10 days post-dose)Population: All participants 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. IMP includes AZD9567, Prednisolone 60 mg and placebo.
Safety and tolerability variables included AEs, vital signs (blood pressure and pulse), ECGs (12-lead ECGs, safety ECGs and telemetry), clinical laboratory safety evaluations (haematology, clinical chemistry \[including osteocalcin\], coagulation, urinalysis \[including 24 hour urine cortisol per day {tU-cortisol}\]) and physical examinations. Note: No clinically relevant findings were noted in clinical laboratory results and vial signs assessments. Hence, none of the laboratory or vital signs findings were reported as AEs.
Outcome measures
| Measure |
AZD9567 - 2 mg
n=6 Participants
In Cohort 1, participants received single dose of AZD8567 2 mg oral suspension in the fasted state
|
AZD9567 - 10 mg
n=6 Participants
In Cohort 2, participants received single dose of AZD8567 10 mg oral suspension in the fasted state
|
AZD9567 - 20 mg
n=6 Participants
In Cohort 3, participants received single dose of AZD8567 20 mg oral suspension in the fasted state
|
AZD9567 - 40 mg
n=6 Participants
In Cohort 4, participants received single dose of AZD8567 40 mg oral suspension in the fasted state
|
AZD9567 - 80 mg
n=6 Participants
In Cohort 5, participants received single dose of AZD8567 80 mg oral suspension in the fasted state
|
AZD9567 - 100 mg
n=6 Participants
In Cohort 6, participants received single dose of AZD8567 100 mg oral suspension in the fasted state
|
AZD9567 - 125 mg
n=6 Participants
In Cohort 7, participants received single dose of AZD8567 125 mg oral suspension in the fasted state
|
AZD9567 - 155 mg
n=6 Participants
In Cohort 8, participants received single dose of AZD8567 155 mg oral suspension in the fasted state
|
Prednisolone - 60 mg
n=6 Participants
In Cohort 9, participants received orally single dose of prednisolone 60 mg capsule in the fasted state
|
Pooled Placebo
n=18 Participants
In Cohort 1-8, participants were randomized to AZD9567:placebo (6:2). In Cohort 9, participants were randomized to prednisolone:placebo (6:2)
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Safety and Tolerability of AZD9567 by Assessing the Number of Participants With Adverse Events
Any AE
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
|
Safety and Tolerability of AZD9567 by Assessing the Number of Participants With Adverse Events
Any AE (including events with outcome =death)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of AZD9567 by Assessing the Number of Participants With Adverse Events
Any serious adverse event (SAE) (including death)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of AZD9567 by Assessing the Number of Participants With Adverse Events
Any AE leading to discontinuation of AZD9567
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: On Day 1 (at pre-dose and at 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours post-dose), Day 2 (24 hours post-dose) and Day 3 (48 hours post-dose)Population: The pharmacokinetic (PK) analysis set consisted of all participants in the safety analysis set who received a dose of AZD9567 and had at least one of the parameters Cmax, AUC / AUC(0-last) evaluable. All protocol deviations were considered for the severity/impact and were accounted when participants were assigned to the PK analysis sets.
To assess the Cmax of AZD9567 oral suspension following 8 single ascending doses (2, 10, 20, 40, 80, 100, 125 and 155 mg) in Cohorts 1 to 8 in the fasted state. Cmax was taken directly from the individual concentration-time curve.
Outcome measures
| Measure |
AZD9567 - 2 mg
n=6 Participants
In Cohort 1, participants received single dose of AZD8567 2 mg oral suspension in the fasted state
|
AZD9567 - 10 mg
n=6 Participants
In Cohort 2, participants received single dose of AZD8567 10 mg oral suspension in the fasted state
|
AZD9567 - 20 mg
n=6 Participants
In Cohort 3, participants received single dose of AZD8567 20 mg oral suspension in the fasted state
|
AZD9567 - 40 mg
n=6 Participants
In Cohort 4, participants received single dose of AZD8567 40 mg oral suspension in the fasted state
|
AZD9567 - 80 mg
n=6 Participants
In Cohort 5, participants received single dose of AZD8567 80 mg oral suspension in the fasted state
|
AZD9567 - 100 mg
n=6 Participants
In Cohort 6, participants received single dose of AZD8567 100 mg oral suspension in the fasted state
|
AZD9567 - 125 mg
n=6 Participants
In Cohort 7, participants received single dose of AZD8567 125 mg oral suspension in the fasted state
|
AZD9567 - 155 mg
n=6 Participants
In Cohort 8, participants received single dose of AZD8567 155 mg oral suspension in the fasted state
|
Prednisolone - 60 mg
In Cohort 9, participants received orally single dose of prednisolone 60 mg capsule in the fasted state
|
Pooled Placebo
In Cohort 1-8, participants were randomized to AZD9567:placebo (6:2). In Cohort 9, participants were randomized to prednisolone:placebo (6:2)
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Rate and Extent of Absorption of Single Ascending Doses of AZD9567 by Assessment of Observed Maximum Plasma Concentration (Cmax)
|
184.9 nmol/L
Geometric Coefficient of Variation 20.18
|
751.6 nmol/L
Geometric Coefficient of Variation 25.03
|
1327 nmol/L
Geometric Coefficient of Variation 17.28
|
2536 nmol/L
Geometric Coefficient of Variation 38.33
|
4261 nmol/L
Geometric Coefficient of Variation 13.88
|
5835 nmol/L
Geometric Coefficient of Variation 14.14
|
6080 nmol/L
Geometric Coefficient of Variation 21.30
|
6900 nmol/L
Geometric Coefficient of Variation 33.97
|
—
|
—
|
PRIMARY outcome
Timeframe: On Day 1 (at pre-dose and at 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours post-dose), Day 2 (24 hours post-dose) and Day 3 (48 hours post-dose)Population: The PK analysis set consisted of all participants in the safety analysis set who received a dose of AZD9567 and had at least one of the parameters Cmax, AUC / AUC(0-last) evaluable. All protocol deviations were considered for the severity/impact and were accounted when participants were assigned to the PK analysis sets.
To assess the tmax of AZD9567 oral suspension following 8 single ascending doses (2, 10, 20, 40, 80, 100, 125 and 155 mg) in Cohorts 1 to 8 in the fasted state. tmax was taken directly from the individual concentration-time curve.
Outcome measures
| Measure |
AZD9567 - 2 mg
n=6 Participants
In Cohort 1, participants received single dose of AZD8567 2 mg oral suspension in the fasted state
|
AZD9567 - 10 mg
n=6 Participants
In Cohort 2, participants received single dose of AZD8567 10 mg oral suspension in the fasted state
|
AZD9567 - 20 mg
n=6 Participants
In Cohort 3, participants received single dose of AZD8567 20 mg oral suspension in the fasted state
|
AZD9567 - 40 mg
n=6 Participants
In Cohort 4, participants received single dose of AZD8567 40 mg oral suspension in the fasted state
|
AZD9567 - 80 mg
n=6 Participants
In Cohort 5, participants received single dose of AZD8567 80 mg oral suspension in the fasted state
|
AZD9567 - 100 mg
n=6 Participants
In Cohort 6, participants received single dose of AZD8567 100 mg oral suspension in the fasted state
|
AZD9567 - 125 mg
n=6 Participants
In Cohort 7, participants received single dose of AZD8567 125 mg oral suspension in the fasted state
|
AZD9567 - 155 mg
n=6 Participants
In Cohort 8, participants received single dose of AZD8567 155 mg oral suspension in the fasted state
|
Prednisolone - 60 mg
In Cohort 9, participants received orally single dose of prednisolone 60 mg capsule in the fasted state
|
Pooled Placebo
In Cohort 1-8, participants were randomized to AZD9567:placebo (6:2). In Cohort 9, participants were randomized to prednisolone:placebo (6:2)
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Rate and Extent of Absorption of Single Ascending Doses of AZD9567 by Assessment of Time to Reach Maximum Plasma Concentration(Tmax)
|
0.50 Hours
Full Range 20.18 • Interval 0.48 to 0.5
|
0.75 Hours
Full Range 25.03 • Interval 0.27 to 1.0
|
0.51 Hours
Full Range 17.28 • Interval 0.5 to 1.5
|
0.75 Hours
Full Range 38.33 • Interval 0.5 to 1.0
|
1.00 Hours
Full Range 13.88 • Interval 1.0 to 1.5
|
1.00 Hours
Full Range 14.14 • Interval 0.5 to 1.5
|
1.00 Hours
Full Range 21.30 • Interval 0.5 to 1.5
|
1.25 Hours
Full Range 33.97 • Interval 0.58 to 2.0
|
—
|
—
|
PRIMARY outcome
Timeframe: On Day 1 (at pre-dose and at 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours post-dose), Day 2 (24 hours post-dose) and Day 3 (48 hours post-dose)Population: The PK analysis set consisted of all participants in the safety analysis set who received a dose of AZD9567 and had at least one of the parameters Cmax, AUC / AUC(0-last) evaluable. All protocol deviations were considered for the severity/impact and were accounted when participants were assigned to the PK analysis sets.
To assess t½λz of AZD9567 oral suspension following 8 single ascending doses (2, 10, 20, 40, 80, 100, 125 and 155 mg) in Cohorts 1 to 8 in the fasted state. t½λz was estimated as (ln2)/λz.
Outcome measures
| Measure |
AZD9567 - 2 mg
n=6 Participants
In Cohort 1, participants received single dose of AZD8567 2 mg oral suspension in the fasted state
|
AZD9567 - 10 mg
n=6 Participants
In Cohort 2, participants received single dose of AZD8567 10 mg oral suspension in the fasted state
|
AZD9567 - 20 mg
n=6 Participants
In Cohort 3, participants received single dose of AZD8567 20 mg oral suspension in the fasted state
|
AZD9567 - 40 mg
n=6 Participants
In Cohort 4, participants received single dose of AZD8567 40 mg oral suspension in the fasted state
|
AZD9567 - 80 mg
n=6 Participants
In Cohort 5, participants received single dose of AZD8567 80 mg oral suspension in the fasted state
|
AZD9567 - 100 mg
n=6 Participants
In Cohort 6, participants received single dose of AZD8567 100 mg oral suspension in the fasted state
|
AZD9567 - 125 mg
n=6 Participants
In Cohort 7, participants received single dose of AZD8567 125 mg oral suspension in the fasted state
|
AZD9567 - 155 mg
n=6 Participants
In Cohort 8, participants received single dose of AZD8567 155 mg oral suspension in the fasted state
|
Prednisolone - 60 mg
In Cohort 9, participants received orally single dose of prednisolone 60 mg capsule in the fasted state
|
Pooled Placebo
In Cohort 1-8, participants were randomized to AZD9567:placebo (6:2). In Cohort 9, participants were randomized to prednisolone:placebo (6:2)
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Rate and Extent of Absorption of Single Ascending Doses of AZD9567 by Assessment of Terminal Half-life (t½λz)
|
4.716 Hours
Standard Deviation 0.8182 • Interval 3.46 to 5.89
|
5.444 Hours
Standard Deviation 2.157 • Interval 2.7 to 9.22
|
3.929 Hours
Standard Deviation 1.237 • Interval 3.13 to 6.31
|
4.199 Hours
Standard Deviation 1.417 • Interval 2.28 to 6.13
|
5.286 Hours
Standard Deviation 1.469 • Interval 3.5 to 6.97
|
5.297 Hours
Standard Deviation 1.041 • Interval 3.89 to 7.02
|
4.664 Hours
Standard Deviation 1.052 • Interval 3.49 to 6.16
|
6.449 Hours
Standard Deviation 1.778 • Interval 4.64 to 8.9
|
—
|
—
|
PRIMARY outcome
Timeframe: On Day 1 (at pre-dose and at 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours post-dose), Day 2 (24 hours post-dose) and Day 3 (48 hours post-dose)Population: The PK analysis set consisted of all participants in the safety analysis set who received a dose of AZD9567 and had at least one of the parameters Cmax, AUC / AUC(0-last) evaluable. All protocol deviations were considered for the severity/impact and were accounted when participants were assigned to the PK analysis sets.
To assess AUC(0-last) of AZD9567 oral suspension following 8 single ascending doses (2, 10, 20, 40, 80, 100, 125 and 155 mg) in Cohorts 1 to 8 in the fasted state.
Outcome measures
| Measure |
AZD9567 - 2 mg
n=6 Participants
In Cohort 1, participants received single dose of AZD8567 2 mg oral suspension in the fasted state
|
AZD9567 - 10 mg
n=6 Participants
In Cohort 2, participants received single dose of AZD8567 10 mg oral suspension in the fasted state
|
AZD9567 - 20 mg
n=6 Participants
In Cohort 3, participants received single dose of AZD8567 20 mg oral suspension in the fasted state
|
AZD9567 - 40 mg
n=6 Participants
In Cohort 4, participants received single dose of AZD8567 40 mg oral suspension in the fasted state
|
AZD9567 - 80 mg
n=6 Participants
In Cohort 5, participants received single dose of AZD8567 80 mg oral suspension in the fasted state
|
AZD9567 - 100 mg
n=6 Participants
In Cohort 6, participants received single dose of AZD8567 100 mg oral suspension in the fasted state
|
AZD9567 - 125 mg
n=6 Participants
In Cohort 7, participants received single dose of AZD8567 125 mg oral suspension in the fasted state
|
AZD9567 - 155 mg
n=6 Participants
In Cohort 8, participants received single dose of AZD8567 155 mg oral suspension in the fasted state
|
Prednisolone - 60 mg
In Cohort 9, participants received orally single dose of prednisolone 60 mg capsule in the fasted state
|
Pooled Placebo
In Cohort 1-8, participants were randomized to AZD9567:placebo (6:2). In Cohort 9, participants were randomized to prednisolone:placebo (6:2)
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Rate and Extent of Absorption of Single Ascending Doses of AZD9567 by Assessment of Area Under the Plasma Concentration-curve From Time Zero to the Time of Last Quantifiable Analyte Concentration (AUC(0-last))
|
940.6 h*nmol/L
Geometric Coefficient of Variation 40.32 • Interval 3.46 to 5.89
|
5069 h*nmol/L
Geometric Coefficient of Variation 41.83 • Interval 2.7 to 9.22
|
7598 h*nmol/L
Geometric Coefficient of Variation 28.12 • Interval 3.13 to 6.31
|
13860 h*nmol/L
Geometric Coefficient of Variation 62.81 • Interval 2.28 to 6.13
|
31600 h*nmol/L
Geometric Coefficient of Variation 34.57 • Interval 3.5 to 6.97
|
41850 h*nmol/L
Geometric Coefficient of Variation 27.82 • Interval 3.89 to 7.02
|
40930 h*nmol/L
Geometric Coefficient of Variation 14.32 • Interval 3.49 to 6.16
|
56940 h*nmol/L
Geometric Coefficient of Variation 36.80 • Interval 4.64 to 8.9
|
—
|
—
|
PRIMARY outcome
Timeframe: On Day 1 (at pre-dose and at 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours post-dose), Day 2 (24 hours post-dose) and Day 3 (48 hours post-dose)Population: The PK analysis set consisted of all participants in the safety analysis set who received a dose of AZD9567 and had at least one of the parameters Cmax, AUC / AUC(0-last) evaluable. All protocol deviations were considered for the severity/impact and were accounted when participants were assigned to the PK analysis sets.
To assess AUC of AZD9567 oral suspension following 8 single ascending doses (2, 10, 20, 40, 80, 100, 125 and 155 mg) in Cohorts 1 to 8 in the fasted state. AUC was estimated by AUC(0-last) + Clast/λz. Clast - the last observed quantifiable concentration.
Outcome measures
| Measure |
AZD9567 - 2 mg
n=6 Participants
In Cohort 1, participants received single dose of AZD8567 2 mg oral suspension in the fasted state
|
AZD9567 - 10 mg
n=6 Participants
In Cohort 2, participants received single dose of AZD8567 10 mg oral suspension in the fasted state
|
AZD9567 - 20 mg
n=6 Participants
In Cohort 3, participants received single dose of AZD8567 20 mg oral suspension in the fasted state
|
AZD9567 - 40 mg
n=6 Participants
In Cohort 4, participants received single dose of AZD8567 40 mg oral suspension in the fasted state
|
AZD9567 - 80 mg
n=6 Participants
In Cohort 5, participants received single dose of AZD8567 80 mg oral suspension in the fasted state
|
AZD9567 - 100 mg
n=6 Participants
In Cohort 6, participants received single dose of AZD8567 100 mg oral suspension in the fasted state
|
AZD9567 - 125 mg
n=6 Participants
In Cohort 7, participants received single dose of AZD8567 125 mg oral suspension in the fasted state
|
AZD9567 - 155 mg
n=6 Participants
In Cohort 8, participants received single dose of AZD8567 155 mg oral suspension in the fasted state
|
Prednisolone - 60 mg
In Cohort 9, participants received orally single dose of prednisolone 60 mg capsule in the fasted state
|
Pooled Placebo
In Cohort 1-8, participants were randomized to AZD9567:placebo (6:2). In Cohort 9, participants were randomized to prednisolone:placebo (6:2)
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Rate and Extent of Absorption of Single Ascending Doses of AZD9567 by Assessment of Area Under the Plasma Concentration-curve From Time Zero Extrapolated to Infinity (AUC)
|
1007 h*nmol/L
Geometric Coefficient of Variation 38.22 • Interval 3.46 to 5.89
|
5266 h*nmol/L
Geometric Coefficient of Variation 42.57 • Interval 2.7 to 9.22
|
7670 h*nmol/L
Geometric Coefficient of Variation 28.26 • Interval 3.13 to 6.31
|
14000 h*nmol/L
Geometric Coefficient of Variation 62.53 • Interval 2.28 to 6.13
|
31840 h*nmol/L
Geometric Coefficient of Variation 34.55 • Interval 3.5 to 6.97
|
42080 h*nmol/L
Geometric Coefficient of Variation 27.83 • Interval 3.89 to 7.02
|
41290 h*nmol/L
Geometric Coefficient of Variation 14.63 • Interval 3.49 to 6.16
|
57500 h*nmol/L
Geometric Coefficient of Variation 37.51 • Interval 4.64 to 8.9
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day -1 (baseline) and Day 1 (pre glucose intake and at 30, 60, 90, 120, 150, 180 and 240 minutes post glucose intake)Population: The pharmacodynamics (PD) analysis set consisted of all participants who received a dose of AZD9567/placebo and who had at least one pre-dose and one post-dose measurement for one of plasma glucose, insulin and C-peptide, and who had no major protocol deviations thought to have impacted the analysis of the PD data.
To assess the effect of AZD9567 and prednisolone on OGTT after administration of 75 g glucose solution, blood samples were collected pre glucose intake and at post glucose intake for the analyses of plasma glucose. AUC0-4h relative change between Day 1 and Day -1 was calculated for each subject in a specific treatment group. Note: Total AUC0-4h was calculated using the linear trapezoidal method. Statistical analysis for the change in OGTT plasma glucose total AUC0-4h values were assessed via an analysis of variance (ANCOVA), with treatment as fixed effect.
Outcome measures
| Measure |
AZD9567 - 2 mg
n=6 Participants
In Cohort 1, participants received single dose of AZD8567 2 mg oral suspension in the fasted state
|
AZD9567 - 10 mg
n=6 Participants
In Cohort 2, participants received single dose of AZD8567 10 mg oral suspension in the fasted state
|
AZD9567 - 20 mg
n=6 Participants
In Cohort 3, participants received single dose of AZD8567 20 mg oral suspension in the fasted state
|
AZD9567 - 40 mg
n=6 Participants
In Cohort 4, participants received single dose of AZD8567 40 mg oral suspension in the fasted state
|
AZD9567 - 80 mg
n=6 Participants
In Cohort 5, participants received single dose of AZD8567 80 mg oral suspension in the fasted state
|
AZD9567 - 100 mg
n=6 Participants
In Cohort 6, participants received single dose of AZD8567 100 mg oral suspension in the fasted state
|
AZD9567 - 125 mg
n=6 Participants
In Cohort 7, participants received single dose of AZD8567 125 mg oral suspension in the fasted state
|
AZD9567 - 155 mg
n=6 Participants
In Cohort 8, participants received single dose of AZD8567 155 mg oral suspension in the fasted state
|
Prednisolone - 60 mg
n=6 Participants
In Cohort 9, participants received orally single dose of prednisolone 60 mg capsule in the fasted state
|
Pooled Placebo
n=18 Participants
In Cohort 1-8, participants were randomized to AZD9567:placebo (6:2). In Cohort 9, participants were randomized to prednisolone:placebo (6:2)
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Secondary Outcome: Relative Change From Baseline of AUC0-4h for Plasma Glucose to Assess the Effects on Glucose Homeostasis (Oral Glucose Tolerance Test [OGTT])
|
1.04 min*mmol/L
Interval 0.963 to 1.12
|
1.01 min*mmol/L
Interval 0.932 to 1.09
|
1.07 min*mmol/L
Interval 0.99 to 1.15
|
1.06 min*mmol/L
Interval 0.986 to 1.14
|
1.08 min*mmol/L
Interval 0.999 to 1.16
|
1.17 min*mmol/L
Interval 1.09 to 1.26
|
1.16 min*mmol/L
Interval 1.08 to 1.25
|
1.20 min*mmol/L
Interval 1.12 to 1.3
|
1.19 min*mmol/L
Interval 1.11 to 1.29
|
1.01 min*mmol/L
Interval 0.964 to 1.05
|
SECONDARY outcome
Timeframe: At Day -1 (baseline) and Day 1 (pre glucose intake and at 30, 60, 90, 120, 150, 180 and 240 minutes post glucose intake)Population: The PD analysis set consisted of all participants who received a dose of AZD9567/placebo and who had at least one pre-dose and one post-dose measurement for one of plasma glucose, insulin and C-peptide, and who had no major protocol deviations thought to have impacted the analysis of the PD data.
To assess the effect of AZD9567 and prednisolone on OGTT after administration of 75 g glucose solution, blood samples were collected pre glucose intake and at post glucose intake for the analyses of serum insulin. AUC0-4h relative change between Day 1 and Day -1 was calculated for each subject in a specific treatment group. Note: Total AUC0-4h was calculated using the linear trapezoidal method. Statistical analysis for the change in OGTT serum insulin total AUC0-4h values were assessed via an analysis of variance (ANCOVA), with treatment as fixed effect.
Outcome measures
| Measure |
AZD9567 - 2 mg
n=6 Participants
In Cohort 1, participants received single dose of AZD8567 2 mg oral suspension in the fasted state
|
AZD9567 - 10 mg
n=6 Participants
In Cohort 2, participants received single dose of AZD8567 10 mg oral suspension in the fasted state
|
AZD9567 - 20 mg
n=6 Participants
In Cohort 3, participants received single dose of AZD8567 20 mg oral suspension in the fasted state
|
AZD9567 - 40 mg
n=6 Participants
In Cohort 4, participants received single dose of AZD8567 40 mg oral suspension in the fasted state
|
AZD9567 - 80 mg
n=6 Participants
In Cohort 5, participants received single dose of AZD8567 80 mg oral suspension in the fasted state
|
AZD9567 - 100 mg
n=6 Participants
In Cohort 6, participants received single dose of AZD8567 100 mg oral suspension in the fasted state
|
AZD9567 - 125 mg
n=6 Participants
In Cohort 7, participants received single dose of AZD8567 125 mg oral suspension in the fasted state
|
AZD9567 - 155 mg
n=6 Participants
In Cohort 8, participants received single dose of AZD8567 155 mg oral suspension in the fasted state
|
Prednisolone - 60 mg
n=6 Participants
In Cohort 9, participants received orally single dose of prednisolone 60 mg capsule in the fasted state
|
Pooled Placebo
n=18 Participants
In Cohort 1-8, participants were randomized to AZD9567:placebo (6:2). In Cohort 9, participants were randomized to prednisolone:placebo (6:2)
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Relative Change From Baseline of AUC0-4h for Serum Insulin to Assess the Effects on Glucose Homeostasis (Oral Glucose Tolerance Test [OGTT])
|
1.19 min*pmol/L
Interval 0.987 to 1.45
|
1.20 min*pmol/L
Interval 0.99 to 1.45
|
1.03 min*pmol/L
Interval 0.838 to 1.28
|
1.04 min*pmol/L
Interval 0.863 to 1.26
|
0.999 min*pmol/L
Interval 0.824 to 1.21
|
0.980 min*pmol/L
Interval 0.811 to 1.18
|
1.15 min*pmol/L
Interval 0.953 to 1.39
|
1.16 min*pmol/L
Interval 0.958 to 1.4
|
0.784 min*pmol/L
Interval 0.648 to 0.947
|
1.14 min*pmol/L
Interval 1.02 to 1.27
|
SECONDARY outcome
Timeframe: At Day -1 (baseline) and Day 1 (pre glucose intake and at 30, 60, 90, 120, 150, 180 and 240 minutes post glucose intake)Population: The PD analysis set consisted of all participants who received a dose of AZD9567/placebo and who had at least one pre-dose and one post-dose measurement for one of plasma glucose, insulin and C-peptide, and who had no major protocol deviations thought to have impacted the analysis of the PD data.
To assess the effect of AZD9567 and prednisolone on OGTT after administration of 75 g glucose solution, blood samples were collected pre glucose intake and at post glucose intake for the analyses of serum C-peptide. AUC0-4h relative change between Day 1 and Day -1 was calculated for each subject in a specific treatment group. Note: Total AUC0-4h was calculated using the linear trapezoidal method. Statistical analysis for the change in OGTT serum C-peptide total AUC0-4h values were assessed via an analysis of variance (ANCOVA), with treatment as fixed effect.
Outcome measures
| Measure |
AZD9567 - 2 mg
n=6 Participants
In Cohort 1, participants received single dose of AZD8567 2 mg oral suspension in the fasted state
|
AZD9567 - 10 mg
n=6 Participants
In Cohort 2, participants received single dose of AZD8567 10 mg oral suspension in the fasted state
|
AZD9567 - 20 mg
n=6 Participants
In Cohort 3, participants received single dose of AZD8567 20 mg oral suspension in the fasted state
|
AZD9567 - 40 mg
n=6 Participants
In Cohort 4, participants received single dose of AZD8567 40 mg oral suspension in the fasted state
|
AZD9567 - 80 mg
n=6 Participants
In Cohort 5, participants received single dose of AZD8567 80 mg oral suspension in the fasted state
|
AZD9567 - 100 mg
n=6 Participants
In Cohort 6, participants received single dose of AZD8567 100 mg oral suspension in the fasted state
|
AZD9567 - 125 mg
n=6 Participants
In Cohort 7, participants received single dose of AZD8567 125 mg oral suspension in the fasted state
|
AZD9567 - 155 mg
n=6 Participants
In Cohort 8, participants received single dose of AZD8567 155 mg oral suspension in the fasted state
|
Prednisolone - 60 mg
n=6 Participants
In Cohort 9, participants received orally single dose of prednisolone 60 mg capsule in the fasted state
|
Pooled Placebo
n=18 Participants
In Cohort 1-8, participants were randomized to AZD9567:placebo (6:2). In Cohort 9, participants were randomized to prednisolone:placebo (6:2)
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Relative Change From Baseline of AUC0-4h for Serum C-peptide to Assess the Effects on Glucose Homeostasis (Oral Glucose Tolerance Test [OGTT])
|
1.06 min*nmol/L
Interval 0.929 to 1.22
|
1.04 min*nmol/L
Interval 0.913 to 1.19
|
1.02 min*nmol/L
Interval 0.895 to 1.17
|
0.933 min*nmol/L
Interval 0.816 to 1.07
|
0.919 min*nmol/L
Interval 0.804 to 1.05
|
1.00 min*nmol/L
Interval 0.879 to 1.15
|
0.983 min*nmol/L
Interval 0.861 to 1.12
|
0.968 min*nmol/L
Interval 0.846 to 1.11
|
0.749 min*nmol/L
Interval 0.655 to 0.856
|
1.08 min*nmol/L
Interval 1.0 to 1.17
|
Adverse Events
AZD9567 - 2 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
AZD9567 - 10 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
AZD9567 - 20 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
AZD9567 - 40 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
AZD9567 - 80 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
AZD9567 - 100 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
AZD9567 - 125 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
AZD9567 - 155 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Prednisolone - 60 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Pooled Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
AZD9567 - 2 mg
n=6 participants at risk
In Cohort 1, participants received single dose of AZD8567 2 mg oral suspension in the fasted state
|
AZD9567 - 10 mg
n=6 participants at risk
In Cohort 2, participants received single dose of AZD8567 10 mg oral suspension in the fasted state
|
AZD9567 - 20 mg
n=6 participants at risk
In Cohort 3, participants received single dose of AZD8567 20 mg oral suspension in the fasted state
|
AZD9567 - 40 mg
n=6 participants at risk
In Cohort 4, participants received single dose of AZD8567 40 mg oral suspension in the fasted state
|
AZD9567 - 80 mg
n=6 participants at risk
In Cohort 5, participants received single dose of AZD8567 80 mg oral suspension in the fasted state
|
AZD9567 - 100 mg
n=6 participants at risk
In Cohort 6, participants received single dose of AZD8567 100 mg oral suspension in the fasted state
|
AZD9567 - 125 mg
n=6 participants at risk
In Cohort 7, participants received single dose of AZD8567 125 mg oral suspension in the fasted state
|
AZD9567 - 155 mg
n=6 participants at risk
In Cohort 8, participants received single dose of AZD8567 155 mg oral suspension in the fasted state
|
Prednisolone - 60 mg
n=6 participants at risk
In Cohort 9, participants received orally single dose of prednisolone 60 mg capsule in the fasted state
|
Pooled Placebo
n=18 participants at risk
In Cohort 1-8, participants were randomized to AZD9567:placebo (6:2). In Cohort 9, participants were randomized to prednisolone:placebo (6:2)
|
|---|---|---|---|---|---|---|---|---|---|---|
|
General disorders
Chest pain
|
0.00%
0/6 • At screening, Day -2, Day -1, Day 1 (at pre-dose; 3 & 12 hours post-dose), Day 2 (24 hours post-dose), Day 3 and follow-up (7 to 10 days after dose)
Standard adverse event collection. An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product
|
0.00%
0/6 • At screening, Day -2, Day -1, Day 1 (at pre-dose; 3 & 12 hours post-dose), Day 2 (24 hours post-dose), Day 3 and follow-up (7 to 10 days after dose)
Standard adverse event collection. An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product
|
16.7%
1/6 • At screening, Day -2, Day -1, Day 1 (at pre-dose; 3 & 12 hours post-dose), Day 2 (24 hours post-dose), Day 3 and follow-up (7 to 10 days after dose)
Standard adverse event collection. An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product
|
0.00%
0/6 • At screening, Day -2, Day -1, Day 1 (at pre-dose; 3 & 12 hours post-dose), Day 2 (24 hours post-dose), Day 3 and follow-up (7 to 10 days after dose)
Standard adverse event collection. An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product
|
0.00%
0/6 • At screening, Day -2, Day -1, Day 1 (at pre-dose; 3 & 12 hours post-dose), Day 2 (24 hours post-dose), Day 3 and follow-up (7 to 10 days after dose)
Standard adverse event collection. An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product
|
0.00%
0/6 • At screening, Day -2, Day -1, Day 1 (at pre-dose; 3 & 12 hours post-dose), Day 2 (24 hours post-dose), Day 3 and follow-up (7 to 10 days after dose)
Standard adverse event collection. An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product
|
0.00%
0/6 • At screening, Day -2, Day -1, Day 1 (at pre-dose; 3 & 12 hours post-dose), Day 2 (24 hours post-dose), Day 3 and follow-up (7 to 10 days after dose)
Standard adverse event collection. An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product
|
0.00%
0/6 • At screening, Day -2, Day -1, Day 1 (at pre-dose; 3 & 12 hours post-dose), Day 2 (24 hours post-dose), Day 3 and follow-up (7 to 10 days after dose)
Standard adverse event collection. An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product
|
0.00%
0/6 • At screening, Day -2, Day -1, Day 1 (at pre-dose; 3 & 12 hours post-dose), Day 2 (24 hours post-dose), Day 3 and follow-up (7 to 10 days after dose)
Standard adverse event collection. An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product
|
0.00%
0/18 • At screening, Day -2, Day -1, Day 1 (at pre-dose; 3 & 12 hours post-dose), Day 2 (24 hours post-dose), Day 3 and follow-up (7 to 10 days after dose)
Standard adverse event collection. An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product
|
|
General disorders
Feeling hot
|
0.00%
0/6 • At screening, Day -2, Day -1, Day 1 (at pre-dose; 3 & 12 hours post-dose), Day 2 (24 hours post-dose), Day 3 and follow-up (7 to 10 days after dose)
Standard adverse event collection. An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product
|
0.00%
0/6 • At screening, Day -2, Day -1, Day 1 (at pre-dose; 3 & 12 hours post-dose), Day 2 (24 hours post-dose), Day 3 and follow-up (7 to 10 days after dose)
Standard adverse event collection. An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product
|
0.00%
0/6 • At screening, Day -2, Day -1, Day 1 (at pre-dose; 3 & 12 hours post-dose), Day 2 (24 hours post-dose), Day 3 and follow-up (7 to 10 days after dose)
Standard adverse event collection. An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product
|
0.00%
0/6 • At screening, Day -2, Day -1, Day 1 (at pre-dose; 3 & 12 hours post-dose), Day 2 (24 hours post-dose), Day 3 and follow-up (7 to 10 days after dose)
Standard adverse event collection. An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product
|
0.00%
0/6 • At screening, Day -2, Day -1, Day 1 (at pre-dose; 3 & 12 hours post-dose), Day 2 (24 hours post-dose), Day 3 and follow-up (7 to 10 days after dose)
Standard adverse event collection. An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product
|
16.7%
1/6 • At screening, Day -2, Day -1, Day 1 (at pre-dose; 3 & 12 hours post-dose), Day 2 (24 hours post-dose), Day 3 and follow-up (7 to 10 days after dose)
Standard adverse event collection. An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product
|
0.00%
0/6 • At screening, Day -2, Day -1, Day 1 (at pre-dose; 3 & 12 hours post-dose), Day 2 (24 hours post-dose), Day 3 and follow-up (7 to 10 days after dose)
Standard adverse event collection. An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product
|
0.00%
0/6 • At screening, Day -2, Day -1, Day 1 (at pre-dose; 3 & 12 hours post-dose), Day 2 (24 hours post-dose), Day 3 and follow-up (7 to 10 days after dose)
Standard adverse event collection. An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product
|
0.00%
0/6 • At screening, Day -2, Day -1, Day 1 (at pre-dose; 3 & 12 hours post-dose), Day 2 (24 hours post-dose), Day 3 and follow-up (7 to 10 days after dose)
Standard adverse event collection. An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product
|
0.00%
0/18 • At screening, Day -2, Day -1, Day 1 (at pre-dose; 3 & 12 hours post-dose), Day 2 (24 hours post-dose), Day 3 and follow-up (7 to 10 days after dose)
Standard adverse event collection. An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product
|
|
General disorders
Vessel puncture site pain
|
0.00%
0/6 • At screening, Day -2, Day -1, Day 1 (at pre-dose; 3 & 12 hours post-dose), Day 2 (24 hours post-dose), Day 3 and follow-up (7 to 10 days after dose)
Standard adverse event collection. An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product
|
0.00%
0/6 • At screening, Day -2, Day -1, Day 1 (at pre-dose; 3 & 12 hours post-dose), Day 2 (24 hours post-dose), Day 3 and follow-up (7 to 10 days after dose)
Standard adverse event collection. An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product
|
0.00%
0/6 • At screening, Day -2, Day -1, Day 1 (at pre-dose; 3 & 12 hours post-dose), Day 2 (24 hours post-dose), Day 3 and follow-up (7 to 10 days after dose)
Standard adverse event collection. An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product
|
0.00%
0/6 • At screening, Day -2, Day -1, Day 1 (at pre-dose; 3 & 12 hours post-dose), Day 2 (24 hours post-dose), Day 3 and follow-up (7 to 10 days after dose)
Standard adverse event collection. An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product
|
0.00%
0/6 • At screening, Day -2, Day -1, Day 1 (at pre-dose; 3 & 12 hours post-dose), Day 2 (24 hours post-dose), Day 3 and follow-up (7 to 10 days after dose)
Standard adverse event collection. An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product
|
0.00%
0/6 • At screening, Day -2, Day -1, Day 1 (at pre-dose; 3 & 12 hours post-dose), Day 2 (24 hours post-dose), Day 3 and follow-up (7 to 10 days after dose)
Standard adverse event collection. An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product
|
0.00%
0/6 • At screening, Day -2, Day -1, Day 1 (at pre-dose; 3 & 12 hours post-dose), Day 2 (24 hours post-dose), Day 3 and follow-up (7 to 10 days after dose)
Standard adverse event collection. An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product
|
0.00%
0/6 • At screening, Day -2, Day -1, Day 1 (at pre-dose; 3 & 12 hours post-dose), Day 2 (24 hours post-dose), Day 3 and follow-up (7 to 10 days after dose)
Standard adverse event collection. An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product
|
0.00%
0/6 • At screening, Day -2, Day -1, Day 1 (at pre-dose; 3 & 12 hours post-dose), Day 2 (24 hours post-dose), Day 3 and follow-up (7 to 10 days after dose)
Standard adverse event collection. An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product
|
5.6%
1/18 • At screening, Day -2, Day -1, Day 1 (at pre-dose; 3 & 12 hours post-dose), Day 2 (24 hours post-dose), Day 3 and follow-up (7 to 10 days after dose)
Standard adverse event collection. An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/6 • At screening, Day -2, Day -1, Day 1 (at pre-dose; 3 & 12 hours post-dose), Day 2 (24 hours post-dose), Day 3 and follow-up (7 to 10 days after dose)
Standard adverse event collection. An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product
|
0.00%
0/6 • At screening, Day -2, Day -1, Day 1 (at pre-dose; 3 & 12 hours post-dose), Day 2 (24 hours post-dose), Day 3 and follow-up (7 to 10 days after dose)
Standard adverse event collection. An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product
|
0.00%
0/6 • At screening, Day -2, Day -1, Day 1 (at pre-dose; 3 & 12 hours post-dose), Day 2 (24 hours post-dose), Day 3 and follow-up (7 to 10 days after dose)
Standard adverse event collection. An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product
|
0.00%
0/6 • At screening, Day -2, Day -1, Day 1 (at pre-dose; 3 & 12 hours post-dose), Day 2 (24 hours post-dose), Day 3 and follow-up (7 to 10 days after dose)
Standard adverse event collection. An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product
|
0.00%
0/6 • At screening, Day -2, Day -1, Day 1 (at pre-dose; 3 & 12 hours post-dose), Day 2 (24 hours post-dose), Day 3 and follow-up (7 to 10 days after dose)
Standard adverse event collection. An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product
|
16.7%
1/6 • At screening, Day -2, Day -1, Day 1 (at pre-dose; 3 & 12 hours post-dose), Day 2 (24 hours post-dose), Day 3 and follow-up (7 to 10 days after dose)
Standard adverse event collection. An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product
|
0.00%
0/6 • At screening, Day -2, Day -1, Day 1 (at pre-dose; 3 & 12 hours post-dose), Day 2 (24 hours post-dose), Day 3 and follow-up (7 to 10 days after dose)
Standard adverse event collection. An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product
|
0.00%
0/6 • At screening, Day -2, Day -1, Day 1 (at pre-dose; 3 & 12 hours post-dose), Day 2 (24 hours post-dose), Day 3 and follow-up (7 to 10 days after dose)
Standard adverse event collection. An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product
|
0.00%
0/6 • At screening, Day -2, Day -1, Day 1 (at pre-dose; 3 & 12 hours post-dose), Day 2 (24 hours post-dose), Day 3 and follow-up (7 to 10 days after dose)
Standard adverse event collection. An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product
|
0.00%
0/18 • At screening, Day -2, Day -1, Day 1 (at pre-dose; 3 & 12 hours post-dose), Day 2 (24 hours post-dose), Day 3 and follow-up (7 to 10 days after dose)
Standard adverse event collection. An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product
|
|
Infections and infestations
Oral herpes
|
0.00%
0/6 • At screening, Day -2, Day -1, Day 1 (at pre-dose; 3 & 12 hours post-dose), Day 2 (24 hours post-dose), Day 3 and follow-up (7 to 10 days after dose)
Standard adverse event collection. An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product
|
0.00%
0/6 • At screening, Day -2, Day -1, Day 1 (at pre-dose; 3 & 12 hours post-dose), Day 2 (24 hours post-dose), Day 3 and follow-up (7 to 10 days after dose)
Standard adverse event collection. An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product
|
0.00%
0/6 • At screening, Day -2, Day -1, Day 1 (at pre-dose; 3 & 12 hours post-dose), Day 2 (24 hours post-dose), Day 3 and follow-up (7 to 10 days after dose)
Standard adverse event collection. An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product
|
0.00%
0/6 • At screening, Day -2, Day -1, Day 1 (at pre-dose; 3 & 12 hours post-dose), Day 2 (24 hours post-dose), Day 3 and follow-up (7 to 10 days after dose)
Standard adverse event collection. An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product
|
0.00%
0/6 • At screening, Day -2, Day -1, Day 1 (at pre-dose; 3 & 12 hours post-dose), Day 2 (24 hours post-dose), Day 3 and follow-up (7 to 10 days after dose)
Standard adverse event collection. An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product
|
0.00%
0/6 • At screening, Day -2, Day -1, Day 1 (at pre-dose; 3 & 12 hours post-dose), Day 2 (24 hours post-dose), Day 3 and follow-up (7 to 10 days after dose)
Standard adverse event collection. An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product
|
0.00%
0/6 • At screening, Day -2, Day -1, Day 1 (at pre-dose; 3 & 12 hours post-dose), Day 2 (24 hours post-dose), Day 3 and follow-up (7 to 10 days after dose)
Standard adverse event collection. An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product
|
0.00%
0/6 • At screening, Day -2, Day -1, Day 1 (at pre-dose; 3 & 12 hours post-dose), Day 2 (24 hours post-dose), Day 3 and follow-up (7 to 10 days after dose)
Standard adverse event collection. An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product
|
0.00%
0/6 • At screening, Day -2, Day -1, Day 1 (at pre-dose; 3 & 12 hours post-dose), Day 2 (24 hours post-dose), Day 3 and follow-up (7 to 10 days after dose)
Standard adverse event collection. An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product
|
5.6%
1/18 • At screening, Day -2, Day -1, Day 1 (at pre-dose; 3 & 12 hours post-dose), Day 2 (24 hours post-dose), Day 3 and follow-up (7 to 10 days after dose)
Standard adverse event collection. An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • At screening, Day -2, Day -1, Day 1 (at pre-dose; 3 & 12 hours post-dose), Day 2 (24 hours post-dose), Day 3 and follow-up (7 to 10 days after dose)
Standard adverse event collection. An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product
|
0.00%
0/6 • At screening, Day -2, Day -1, Day 1 (at pre-dose; 3 & 12 hours post-dose), Day 2 (24 hours post-dose), Day 3 and follow-up (7 to 10 days after dose)
Standard adverse event collection. An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product
|
0.00%
0/6 • At screening, Day -2, Day -1, Day 1 (at pre-dose; 3 & 12 hours post-dose), Day 2 (24 hours post-dose), Day 3 and follow-up (7 to 10 days after dose)
Standard adverse event collection. An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product
|
0.00%
0/6 • At screening, Day -2, Day -1, Day 1 (at pre-dose; 3 & 12 hours post-dose), Day 2 (24 hours post-dose), Day 3 and follow-up (7 to 10 days after dose)
Standard adverse event collection. An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product
|
0.00%
0/6 • At screening, Day -2, Day -1, Day 1 (at pre-dose; 3 & 12 hours post-dose), Day 2 (24 hours post-dose), Day 3 and follow-up (7 to 10 days after dose)
Standard adverse event collection. An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product
|
16.7%
1/6 • At screening, Day -2, Day -1, Day 1 (at pre-dose; 3 & 12 hours post-dose), Day 2 (24 hours post-dose), Day 3 and follow-up (7 to 10 days after dose)
Standard adverse event collection. An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product
|
0.00%
0/6 • At screening, Day -2, Day -1, Day 1 (at pre-dose; 3 & 12 hours post-dose), Day 2 (24 hours post-dose), Day 3 and follow-up (7 to 10 days after dose)
Standard adverse event collection. An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product
|
0.00%
0/6 • At screening, Day -2, Day -1, Day 1 (at pre-dose; 3 & 12 hours post-dose), Day 2 (24 hours post-dose), Day 3 and follow-up (7 to 10 days after dose)
Standard adverse event collection. An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product
|
0.00%
0/6 • At screening, Day -2, Day -1, Day 1 (at pre-dose; 3 & 12 hours post-dose), Day 2 (24 hours post-dose), Day 3 and follow-up (7 to 10 days after dose)
Standard adverse event collection. An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product
|
0.00%
0/18 • At screening, Day -2, Day -1, Day 1 (at pre-dose; 3 & 12 hours post-dose), Day 2 (24 hours post-dose), Day 3 and follow-up (7 to 10 days after dose)
Standard adverse event collection. An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product
|
|
Vascular disorders
Hot flush
|
0.00%
0/6 • At screening, Day -2, Day -1, Day 1 (at pre-dose; 3 & 12 hours post-dose), Day 2 (24 hours post-dose), Day 3 and follow-up (7 to 10 days after dose)
Standard adverse event collection. An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product
|
0.00%
0/6 • At screening, Day -2, Day -1, Day 1 (at pre-dose; 3 & 12 hours post-dose), Day 2 (24 hours post-dose), Day 3 and follow-up (7 to 10 days after dose)
Standard adverse event collection. An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product
|
0.00%
0/6 • At screening, Day -2, Day -1, Day 1 (at pre-dose; 3 & 12 hours post-dose), Day 2 (24 hours post-dose), Day 3 and follow-up (7 to 10 days after dose)
Standard adverse event collection. An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product
|
0.00%
0/6 • At screening, Day -2, Day -1, Day 1 (at pre-dose; 3 & 12 hours post-dose), Day 2 (24 hours post-dose), Day 3 and follow-up (7 to 10 days after dose)
Standard adverse event collection. An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product
|
0.00%
0/6 • At screening, Day -2, Day -1, Day 1 (at pre-dose; 3 & 12 hours post-dose), Day 2 (24 hours post-dose), Day 3 and follow-up (7 to 10 days after dose)
Standard adverse event collection. An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product
|
0.00%
0/6 • At screening, Day -2, Day -1, Day 1 (at pre-dose; 3 & 12 hours post-dose), Day 2 (24 hours post-dose), Day 3 and follow-up (7 to 10 days after dose)
Standard adverse event collection. An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product
|
16.7%
1/6 • At screening, Day -2, Day -1, Day 1 (at pre-dose; 3 & 12 hours post-dose), Day 2 (24 hours post-dose), Day 3 and follow-up (7 to 10 days after dose)
Standard adverse event collection. An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product
|
0.00%
0/6 • At screening, Day -2, Day -1, Day 1 (at pre-dose; 3 & 12 hours post-dose), Day 2 (24 hours post-dose), Day 3 and follow-up (7 to 10 days after dose)
Standard adverse event collection. An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product
|
0.00%
0/6 • At screening, Day -2, Day -1, Day 1 (at pre-dose; 3 & 12 hours post-dose), Day 2 (24 hours post-dose), Day 3 and follow-up (7 to 10 days after dose)
Standard adverse event collection. An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product
|
0.00%
0/18 • At screening, Day -2, Day -1, Day 1 (at pre-dose; 3 & 12 hours post-dose), Day 2 (24 hours post-dose), Day 3 and follow-up (7 to 10 days after dose)
Standard adverse event collection. An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • At screening, Day -2, Day -1, Day 1 (at pre-dose; 3 & 12 hours post-dose), Day 2 (24 hours post-dose), Day 3 and follow-up (7 to 10 days after dose)
Standard adverse event collection. An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product
|
0.00%
0/6 • At screening, Day -2, Day -1, Day 1 (at pre-dose; 3 & 12 hours post-dose), Day 2 (24 hours post-dose), Day 3 and follow-up (7 to 10 days after dose)
Standard adverse event collection. An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product
|
0.00%
0/6 • At screening, Day -2, Day -1, Day 1 (at pre-dose; 3 & 12 hours post-dose), Day 2 (24 hours post-dose), Day 3 and follow-up (7 to 10 days after dose)
Standard adverse event collection. An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product
|
0.00%
0/6 • At screening, Day -2, Day -1, Day 1 (at pre-dose; 3 & 12 hours post-dose), Day 2 (24 hours post-dose), Day 3 and follow-up (7 to 10 days after dose)
Standard adverse event collection. An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product
|
0.00%
0/6 • At screening, Day -2, Day -1, Day 1 (at pre-dose; 3 & 12 hours post-dose), Day 2 (24 hours post-dose), Day 3 and follow-up (7 to 10 days after dose)
Standard adverse event collection. An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product
|
0.00%
0/6 • At screening, Day -2, Day -1, Day 1 (at pre-dose; 3 & 12 hours post-dose), Day 2 (24 hours post-dose), Day 3 and follow-up (7 to 10 days after dose)
Standard adverse event collection. An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product
|
0.00%
0/6 • At screening, Day -2, Day -1, Day 1 (at pre-dose; 3 & 12 hours post-dose), Day 2 (24 hours post-dose), Day 3 and follow-up (7 to 10 days after dose)
Standard adverse event collection. An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product
|
0.00%
0/6 • At screening, Day -2, Day -1, Day 1 (at pre-dose; 3 & 12 hours post-dose), Day 2 (24 hours post-dose), Day 3 and follow-up (7 to 10 days after dose)
Standard adverse event collection. An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product
|
0.00%
0/6 • At screening, Day -2, Day -1, Day 1 (at pre-dose; 3 & 12 hours post-dose), Day 2 (24 hours post-dose), Day 3 and follow-up (7 to 10 days after dose)
Standard adverse event collection. An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product
|
5.6%
1/18 • At screening, Day -2, Day -1, Day 1 (at pre-dose; 3 & 12 hours post-dose), Day 2 (24 hours post-dose), Day 3 and follow-up (7 to 10 days after dose)
Standard adverse event collection. An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/6 • At screening, Day -2, Day -1, Day 1 (at pre-dose; 3 & 12 hours post-dose), Day 2 (24 hours post-dose), Day 3 and follow-up (7 to 10 days after dose)
Standard adverse event collection. An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product
|
0.00%
0/6 • At screening, Day -2, Day -1, Day 1 (at pre-dose; 3 & 12 hours post-dose), Day 2 (24 hours post-dose), Day 3 and follow-up (7 to 10 days after dose)
Standard adverse event collection. An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product
|
0.00%
0/6 • At screening, Day -2, Day -1, Day 1 (at pre-dose; 3 & 12 hours post-dose), Day 2 (24 hours post-dose), Day 3 and follow-up (7 to 10 days after dose)
Standard adverse event collection. An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product
|
0.00%
0/6 • At screening, Day -2, Day -1, Day 1 (at pre-dose; 3 & 12 hours post-dose), Day 2 (24 hours post-dose), Day 3 and follow-up (7 to 10 days after dose)
Standard adverse event collection. An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product
|
0.00%
0/6 • At screening, Day -2, Day -1, Day 1 (at pre-dose; 3 & 12 hours post-dose), Day 2 (24 hours post-dose), Day 3 and follow-up (7 to 10 days after dose)
Standard adverse event collection. An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product
|
0.00%
0/6 • At screening, Day -2, Day -1, Day 1 (at pre-dose; 3 & 12 hours post-dose), Day 2 (24 hours post-dose), Day 3 and follow-up (7 to 10 days after dose)
Standard adverse event collection. An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product
|
0.00%
0/6 • At screening, Day -2, Day -1, Day 1 (at pre-dose; 3 & 12 hours post-dose), Day 2 (24 hours post-dose), Day 3 and follow-up (7 to 10 days after dose)
Standard adverse event collection. An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product
|
0.00%
0/6 • At screening, Day -2, Day -1, Day 1 (at pre-dose; 3 & 12 hours post-dose), Day 2 (24 hours post-dose), Day 3 and follow-up (7 to 10 days after dose)
Standard adverse event collection. An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product
|
0.00%
0/6 • At screening, Day -2, Day -1, Day 1 (at pre-dose; 3 & 12 hours post-dose), Day 2 (24 hours post-dose), Day 3 and follow-up (7 to 10 days after dose)
Standard adverse event collection. An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product
|
5.6%
1/18 • At screening, Day -2, Day -1, Day 1 (at pre-dose; 3 & 12 hours post-dose), Day 2 (24 hours post-dose), Day 3 and follow-up (7 to 10 days after dose)
Standard adverse event collection. An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee All clinical study findings and documents will be regarded as confidential. The investigator and members of his/her research team must not disclose such information without prior written approval from the sponsor.
- Publication restrictions are in place
Restriction type: OTHER