Status:
COMPLETED
A Study to Assess the Relative Bioavailability Three New Formulations of Telaprevir in Healthy Subjects
Lead Sponsor:
Vertex Pharmaceuticals Incorporated
Conditions:
Chronic Hepatitis C
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT01511432
Start Date
January 1 2012
End Date
July 1 2012
Last Update
July 4 2012
Active Locations (2)
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1
Texas
Dallas, Texas, United States, 75247
2
Wisconsin
Madison, Wisconsin, United States, 53704