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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02553356 | PT2385-102 Food Effect Study of PT2385 in Healthy Volunteers | PHASE1 | COMPLETED | 16 | — | — | Sep 1, 2015 | Dec 1, 2015 | Dec 10, 2015 | 1 | United States |
Peak Plasma Concentration (Cmax) will be assessed in both the fasting and non-fasting conditions and compared.
| Arm | Type | Description |
|---|---|---|
| Fasted | EXPERIMENTAL | PT2385 taken after fasting. |
| Non-Fasting | EXPERIMENTAL | PT2385 taken after eating a high calorie meal. |
| Name | Type | Description |
|---|---|---|
| PT2385 | DRUG | - |
Inclusion Criteria: * Female between 18 and 45 years of age; * If of childbearing potential, willing to practice methods of birth control; * If of childbearing potential, must be non-pregnant and non-lactating and have a negative serum pregnancy test result prior to enrollment into the trial; * Has...