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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01612143

Enrollment

Registered

2012-06-05

Start date

2012-06-30

Completion date

2012-09-30

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteer

Brief summary

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.

Interventions

DRUGsetrobuvir

200 mg capsule formulation, single oral dose

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 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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Safety: Incidence of adverse events	approximately 2 months

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026