A Study to Assess the Relative Bioavailability Three New Formulations of Telaprevir in Healthy Subjects
Phase 1
Completed
- Conditions
- Chronic Hepatitis C
- Interventions
- Registration Number
- NCT01511432
- Lead Sponsor
- Vertex Pharmaceuticals Incorporated
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 64
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Part B telaprevir Formulation D 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 Part B telaprevir formulation A 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 Part A telaprevir formulation A 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 A telaprevir Formulation B 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 telaprevir Formulation C 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 Part A telaprevir Formulation C 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 telaprevir Formulation B 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 Part A telaprevir Formulation D 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.
- Primary Outcome Measures
Name Time Method PK parameters: Maximum plasma concentration (Cmax), area under the concentration versus time curve (AUC) from time 0 to infinity (AUC0-∞) Up to 57 days • PK parameters: Maximum plasma concentration (Cmax), area under the concentration versus time curve AUC from time 0 to last time point (AUC0-tlast) Up to 57 Days
- Secondary Outcome Measures
Name Time Method The safety and tolerability of 3 oral formulations of telaprevir as assessed by adverse events, serious adverse events and results of clinical laboratory tests (serum chemistry, hematology, and urinalysis), vital signs, and 12-lead electrocardiograms Up to 57days Time to reach Cmax after dosing (tmax) and terminal half-life (t1/2) of telaprevir Up to 57 Days
Trial Locations
- Locations (2)
Texas
🇺🇸Dallas, Texas, United States
Wisconsin
🇺🇸Madison, Wisconsin, United States