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telaprevir formulation A · 1 trial · 1 indication
| 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...
Telaprevir formulation A is an investigational small molecule being studied for chronic Hepatitis C. It is a new formulation of telaprevir, a drug used to treat Hepatitis C. The formulation is being evaluated in clinical trials to assess its bioavailability in healthy subjects.
Telaprevir formulation A is being developed by Vertex Pharmaceuticals Incorporated, a biopharmaceutical company traded on the NASDAQ under the ticker symbol VRTX. The company is conducting clinical research on this formulation for the treatment of chronic Hepatitis C.
Telaprevir formulation A is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 1 trial has been completed, and the formulation remains under clinical investigation for chronic Hepatitis C.
Telaprevir formulation A has been studied in one clinical trial, identified as NCT01511432. This Phase 1 study assessed the relative bioavailability of three new formulations of telaprevir in healthy subjects. The trial enrolled 64 participants and was conducted in the United States.
Telaprevir formulation A is a new formulation of telaprevir, the active pharmaceutical ingredient. The study NCT01511432 evaluated the relative bioavailability of three new formulations of telaprevir, including formulation A, in healthy subjects. It is not a different drug but a modified version of the existing compound.