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

NCT01612143 | Completed Phase 1

• 2 other identifiers: NP283272012-001001-24
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (1)

• Relative bioavailability: Cmax/area under the concentration-time curve (AUC)

  Pre-dose and up to 168 hours post-dose

Secondary Outcomes (1)

• Safety: Incidence of adverse events

  approximately 2 months

Study Arms (4)

A: STV capsule (after high fat meal)

ACTIVE COMPARATOR

Drug: setrobuvir

B: STV capsule (fasted state)

ACTIVE COMPARATOR

Drug: setrobuvir

C: STV tablet (after high fat meal)

EXPERIMENTAL

Drug: setrobuvir

D: STV tablet (fasted state)

EXPERIMENTAL

Drug: setrobuvir

Interventions

setrobuvir DRUG

200 mg capsule formulation, single oral dose

A: STV capsule (after high fat meal); B: STV capsule (fasted state)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

Unknown Facility

Zuidlaren, 9471 GP, Netherlands

Location

MeSH Terms

Interventions

setrobuvir

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2012
• First Posted: June 5, 2012
• Study Start: June 1, 2012
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

NL (1)