Chronic Hepatitis C
Conditions
Keywords
Relative bioavailability, telaprevir formulations
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.
Interventions
DRUGtelaprevir formulation A
A single 1125-mg dose administered orally
DRUGtelaprevir Formulation B
A single 1125-mg dose administered orally
DRUGtelaprevir Formulation C
A single 1125-mg dose administered orally
DRUGtelaprevir Formulation D
A single 1125-mg dose administered orally
Sponsors
Vertex Pharmaceuticals Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed