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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01511432 | A Study to Assess the Relative Bioavailability Three New Formulations of Telaprevir in Healthy Subjects | PHASE1 | COMPLETED | 64 | — | — | Jan 1, 2012 | Jul 1, 2012 | Jul 4, 2012 | 2 | United States |
| Arm | Type | Description |
|---|---|---|
| Part A | EXPERIMENTAL | Part A will be a 4-formulation, 4-sequence, 4-period crossover relative bioavailability study of 3 novel oral telaprevir formulations relative to the 375-mg Incivek tablet in the fed state. |
| Part B | EXPERIMENTAL | Part B will be a 2-formulation, 6-sequence, 3-period cross-over relative bioavailability study of the novel oral telaprevir formulation selected from Part A in the fasted relative to the fed state and relative to the 375-mg Incivek tablet in the fasted state |
| Name | Type | Description |
|---|---|---|
| telaprevir formulation A | DRUG | A single 1125-mg dose administered orally |
| telaprevir Formulation B | DRUG | A single 1125-mg dose administered orally |
| telaprevir Formulation C | DRUG | A single 1125-mg dose administered orally |
| telaprevir Formulation D | DRUG | A single 1125-mg dose administered orally |
Inclusion Criteria: * Healthy subjects (male and female of non-childbearing potential) between the ages of 18 and 55 years * Non-childbearing potential female subjects * Male subjects and female partners must agree to use at least 2 methods of contraception * Subjects with a body mass index (BMI) o...