crossover randomized trial
NCT03309241
A Phase 1, Randomized, Double-blind, Placebo-controlled Study To Assess The Safety, Tolerability, And Pharmacokinetics Of Single Escalating Oral Doses Of Pf-06882961 In Healthy Adult Subjects
Design
Conduct and analysis
Arms
| Arm | Treatment | Background | Randomized | Analyzed | Completed treatment |
|---|---|---|---|---|---|
| A1 | danuglipron PF-06882961 3 mg single dose | lifestyle: none | 6 | ||
| A2 | danuglipron PF-06882961 10 mg single dose | lifestyle: none | 6 | ||
| A3 | danuglipron PF-06882961 30 mg single dose | lifestyle: none | 6 | ||
| A4 | danuglipron PF-06882961 100 mg single dose | lifestyle: none | 6 | ||
| A5 | danuglipron PF-06882961 300 mg single dose | lifestyle: none | 12 | ||
| A6 | Placebo Placebo | lifestyle: none |
Results
18 adjudicated result lines, grouped by outcome. Open an outcome to see its values.
Serious adverse events (6 lines; O25)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / | not stated; other; R0013378:p13 | ||||
| A2 | events | 0 / | not stated; other; R0013378:p13 | ||||
| A3 | events | 0 / | not stated; other; R0013378:p13 | ||||
| A4 | events | 0 / | not stated; other; R0013378:p13 | ||||
| A5 | events | 0 / | not stated; other; R0013378:p13 | ||||
| A6 | events | 0 / | not stated; other; R0013378:p13 |
Discontinuation due to adverse events (6 lines; O26)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / | not stated; other; R0013378:p13 | ||||
| A2 | events | 0 / | not stated; other; R0013378:p13 | ||||
| A3 | events | 0 / | not stated; other; R0013378:p13 | ||||
| A4 | events | 0 / | not stated; other; R0013378:p13 | ||||
| A5 | events | 0 / | not stated; other; R0013378:p13 | ||||
| A6 | events | 0 / | not stated; other; R0013378:p13 |
Discontinuation due to gastrointestinal adverse events (6 lines; O27E)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / | not stated; other; R0013378:p13 | ||||
| A2 | events | 0 / | not stated; other; R0013378:p13 | ||||
| A3 | events | 0 / | not stated; other; R0013378:p13 | ||||
| A4 | events | 0 / | not stated; other; R0013378:p13 | ||||
| A5 | events | 0 / | not stated; other; R0013378:p13 | ||||
| A6 | events | 0 / | not stated; other; R0013378:p13 |