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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01612143
First received: June 1, 2012
Last updated: April 7, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Healthy Volunteer
Drug: setrobuvir
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: 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

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Relative bioavailability: Cmax/area under the concentration-time curve (AUC) [ Time Frame: Pre-dose and up to 168 hours post-dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety: Incidence of adverse events [ Time Frame: approximately 2 months ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: June 2012
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A: STV capsule (after high fat meal) Drug: setrobuvir
200 mg capsule formulation, single oral dose
Active Comparator: B: STV capsule (fasted state) Drug: setrobuvir
200 mg capsule formulation, single oral dose
Experimental: C: STV tablet (after high fat meal) Drug: setrobuvir
200 mg tablet formulation, single oral dose
Experimental: D: STV tablet (fasted state) Drug: setrobuvir
200 mg tablet formulation, single oral dose

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01612143

Locations
Netherlands
Zuidlaren, Netherlands, 9471 GP
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01612143     History of Changes
Other Study ID Numbers: NP28327, 2012-001001-24
Study First Received: June 1, 2012
Last Updated: April 7, 2014
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

ClinicalTrials.gov processed this record on April 17, 2014