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

Roche

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: setrobuvir

Study type: Interventional

Funder types: Industry

Identifiers

NCT01612143

2012-001001-24 (EudraCT Number)

NP28327

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

40 participants in 4 patient groups

A: STV capsule (after high fat meal)

Active Comparator group

Treatment:

Drug: setrobuvir

Drug: setrobuvir

B: STV capsule (fasted state)

Active Comparator group

Treatment:

Drug: setrobuvir

Drug: setrobuvir

C: STV tablet (after high fat meal)

Experimental group

Treatment:

Drug: setrobuvir

Drug: setrobuvir

D: STV tablet (fasted state)

Experimental group

Treatment:

Drug: setrobuvir

Drug: setrobuvir