A Study to Assess the Relative Bioavailability Three New Formulations of Telaprevir in Healthy Subjects

Vertex Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Chronic Hepatitis C

Treatments: Drug: telaprevir Formulation D; Drug: telaprevir Formulation C; Drug: telaprevir formulation A; Drug: telaprevir Formulation B

Study type: Interventional

Funder types: Industry

Identifiers

NCT01511432

VX11-950-025

Details and patient eligibility

About

The purpose of this study is to evaluate the relative bioavailability, safety, and tolerability of 3 new formulations of telaprevir relative to the Incivek 375-mg tablets.

Enrollment: 64 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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) of 18 to 30 kg/m2 and weigh >50 kg at the Screening Visit.

Exclusion criteria

• Subjects with a positive test result for hepatitis B, hepatitis C, or HIV
• Subjects with a significant history of any illness, as deemed important by the investigator or any condition possibly affecting drug absorption
• Subjects with a positive urine screen for drugs of abuse
• Subjects with a history of regular alcohol consumption
• Subjects treated with an investigational drug within 30 days
• For Part A only: Subjects with 12-lead ECG QTcF >450 msec (males) or QTcF >470 msec (females) at the Screening Visit
• Subjects who use prescription and/or nonprescription medications or vitamins and/or dietary supplements
• Subjects who have made a blood donation of approximately 1 pint (500 mL) within 56 days prior to the first dose of study drug
• Subjects who have a female partner who is pregnant, nursing, or planning to become pregnant during the study or within 90 days of the last dose of study drug
• Subjects on hormone replacement therapy (HRT) must discontinue such therapy 28 days prior to the first dose of study drug
• Subjects who have a habit of using tobacco or nicotine containing products within 6 months before the Screening Visit

Trial design

64 participants in 2 patient groups

Part A

Experimental group

Description:

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.

Treatment:

Drug: telaprevir formulation A

Drug: telaprevir Formulation B

Drug: telaprevir Formulation C

Drug: telaprevir Formulation D

Part B

Experimental group

Description:

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

Treatment:

Drug: telaprevir formulation A

Drug: telaprevir Formulation B

Drug: telaprevir Formulation C

Drug: telaprevir Formulation D