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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteer
• Intervention / Treatment: Drug: setrobuvir; Drug: setrobuvir

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• Netherlands
  • Zuidlaren, Netherlands, 9471 GP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: A: STV capsule (after high fat meal)	Drug: setrobuvir; 200 mg capsule formulation, single oral dose; Drug: setrobuvir; 200 mg tablet formulation, single oral dose
ACTIVE_COMPARATOR: B: STV capsule (fasted state)	Drug: setrobuvir; 200 mg capsule formulation, single oral dose; Drug: setrobuvir; 200 mg tablet formulation, single oral dose
EXPERIMENTAL: C: STV tablet (after high fat meal)	Drug: setrobuvir; 200 mg capsule formulation, single oral dose; Drug: setrobuvir; 200 mg tablet formulation, single oral dose
EXPERIMENTAL: D: STV tablet (fasted state)	Drug: setrobuvir; 200 mg capsule formulation, single oral dose; Drug: setrobuvir; 200 mg tablet formulation, single oral dose

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (ACTUAL): September 1, 2012
• Study Completion (ACTUAL): September 1, 2012

Study Registration Dates

• First Submitted: June 1, 2012
• First Submitted That Met QC Criteria: June 1, 2012
• First Posted (ESTIMATE): June 5, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): November 2, 2016
• Last Update Submitted That Met QC Criteria: November 1, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: NP28327; 2012-001001-24 (EUDRACT_NUMBER)