A Relative Bioavailability Study of Setrobuvir Tablet Formulation Versus Reference Setrobuvir Capsule Formulation in Healthy Volunteers

Study Overview
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Brief Summary
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This open-label, randomized, single dose, 4-sequence, 4-period crossover study will assess the relative bioavailability of setrobuvir as tablet formulation versus the reference capsule formulation in healthy volunteers. Subjects will be randomized to one of four treatment sequences receiving 4 single oral doses of 200 mg setrobuvir, either as tablet or capsule formulation with or without a high fat meal, with a washout period of at least 14 days between treatments.

Official Title
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A Randomized, Open-label, Single Dose, Cross-over Study to Investigate the Relative Bioavailability of Setrobuvir (STV) Tablet Formulation Versus the Reference Setrobuvir Capsule Formulation Following Oral Administration With or Without a High Fat Meal in Healthy Subjects

Conditions
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Healthy Volunteer

Intervention / Treatment
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* Drug: setrobuvir
* Drug: setrobuvir


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male and female adults, 18 to 55 years of age inclusive Body mass index (BMI) 18.0 - 30.0 kg/m2 Healthy status defined as absence of clinically significant acute or chronic condition as determined by complete medical history and physical examination Females of childbearing potential and males and their female partner(s) of childbearing potential must agree to use 2 forms of contraception as defined by protocol during treatment and for at least 3 months after the last dose of study drug Non-smokers or use of < 10 cigarettes (or equivalent nicotine-containing product) per day Negative results on following screening laboratory test: urine drug screen, urine alcohol screen Willing and able to consume the study-specified meal on day of dosing Exclusion Criteria: Pregnant or lactating women, or males with female partners who are pregnant or lactating History of current alcohol abuse and/or other drug addiction </= 2 years prior to enrollment in the study Participation in other clinical studies within 60 days prior to study randomization Positive for hepatitis B, hepatitis C or HIV infection

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 |
| --- | --- |
| Active Comparator: A: STV capsule (after high fat meal)<br> | Drug: setrobuvir<br>* 200 mg capsule formulation, single oral dose<br>|
| Active Comparator: B: STV capsule (fasted state)<br> | Drug: setrobuvir<br>* 200 mg capsule formulation, single oral dose<br>|
| Experimental: C: STV tablet (after high fat meal)<br> | Drug: setrobuvir<br>* 200 mg tablet formulation, single oral dose<br>|
| Experimental: D: STV tablet (fasted state)<br> | Drug: setrobuvir<br>* 200 mg tablet formulation, single oral dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relative bioavailability: Cmax/area under the concentration-time curve (AUC) |  | Pre-dose and up to 168 hours post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: Incidence of adverse events |  | approximately 2 months |