A Study to Assess the Relative Bioavailability Three New Formulations of Telaprevir in Healthy Subjects
Completed · Phase 1
Conditions studied: Chronic Hepatitis C
In brief
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.
Key facts
- Study ID
- NCT01511432
- Run by
- Vertex Pharmaceuticals Incorporated
- People needed
- 64
- Starts
- 2012-01-01
- Expected to finish
- 2012-07-01
- Last updated by the study team
- 2012-07-04
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Texas — Dallas, Texas, United States
- Wisconsin — Madison, Wisconsin, United States
Full record on ClinicalTrials.gov
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