A Two-Part, Phase 1, Randomized, Open-Label, Crossover Study to Evaluate the Relative Bioavailability of 3 Novel Oral Formulations of Telaprevir Relative to Incivek 375-mg Tablets When Administered as a Single 1125-mg Dose to Healthy Subjects
Overview
- Phase
- Phase 1
- Intervention
- telaprevir formulation A
- Conditions
- Chronic Hepatitis C
- Sponsor
- Vertex Pharmaceuticals Incorporated
- Enrollment
- 64
- Locations
- 2
- Primary Endpoint
- PK parameters: Maximum plasma concentration (Cmax), area under the concentration versus time curve (AUC) from time 0 to infinity (AUC0-∞)
- Status
- Completed
- Last Updated
- 13 years ago
Overview
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.
Investigators
Eligibility 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
Arms & Interventions
Part 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.
Intervention: telaprevir formulation A
Part 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.
Intervention: telaprevir Formulation B
Part 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.
Intervention: telaprevir Formulation C
Part 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.
Intervention: telaprevir Formulation D
Part 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
Intervention: telaprevir formulation A
Part 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
Intervention: telaprevir Formulation B
Part 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
Intervention: telaprevir Formulation C
Part 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
Intervention: telaprevir Formulation D
Outcomes
Primary Outcomes
PK parameters: Maximum plasma concentration (Cmax), area under the concentration versus time curve (AUC) from time 0 to infinity (AUC0-∞)
Time Frame: 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)
Time Frame: Up to 57 Days
Secondary Outcomes
- 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)