Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03126721 | The Study is to Evaluate the Effect of Multiple Doses PF-06751979 on the Pharmacokinetics of Midazolam in Healthy Adults | PHASE1 | COMPLETED | 12 | — | — | Apr 18, 2017 | Jul 11, 2017 | Jul 26, 2017 | 1 | Belgium |
the plasma midazolam AUC from 0 to tlast (time of last quantifiable concentration) when a single oral midazolam dose given alone
the midazolam Cmax when single oral midazolam dose given alone
the plasma midazolam AUC from 0 to infinity when a single oral midazolam dose given alone
the plasma midazolam AUC from 0 to tlast (time of the last quantifiable concentration) when a single oral midazolam given in presence of steady state PF-06751979
the midazolam Cmax when a single oral midazolam given in presence of steady state PF-06751979
the plasma midazolam AUC from 0 to infinity when a single oral midazolam given in presence of steady state PF-06751979
| Arm | Type | Description |
|---|---|---|
| oral midazolam alone | EXPERIMENTAL | single dose of oral midazolam administered alone in period 1 |
| oral midazolam administered with multiple doses of PF-06751979 | EXPERIMENTAL | single dose of midazolam on day 10 with multiple doses of PF-06751979 once a day on Days 1-11 in period 2 |
| Name | Type | Description |
|---|---|---|
| midazolam | DRUG | a single oral dose of 2 mg midazolam |
| PF-06751979 | DRUG | multiple oral doses of PF-06751979 100 mg a day |
Inclusion Criteria: * Healthy female subjects of nonchildbearing potential and male subjects who, at the time of screening, are between the ages of 18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examinat...