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

• Status: Completed
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Vertex Pharmaceuticals Incorporated

Criteria

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