A Study to Assess the Relative Bioavailability Three New Formulations of Telaprevir in Healthy Subjects

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Chronic Hepatitis C

Intervention / Treatment
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* Drug: telaprevir formulation A
* Drug: telaprevir Formulation B
* Drug: telaprevir Formulation C
* Drug: telaprevir Formulation D


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part A<br>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. | Drug: telaprevir formulation A<br>* A single 1125-mg dose administered orally<br>Drug: telaprevir Formulation B<br>* A single 1125-mg dose administered orally<br>Drug: telaprevir Formulation C<br>* A single 1125-mg dose administered orally<br>Drug: telaprevir Formulation D<br>* A single 1125-mg dose administered orally<br>|
| Experimental: Part B<br>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 | Drug: telaprevir formulation A<br>* A single 1125-mg dose administered orally<br>Drug: telaprevir Formulation B<br>* A single 1125-mg dose administered orally<br>Drug: telaprevir Formulation C<br>* A single 1125-mg dose administered orally<br>Drug: telaprevir Formulation D<br>* A single 1125-mg dose administered orally<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Relative bioavailability, telaprevir formulations