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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01612143
First Posted: June 5, 2012
Last Update Posted: November 2, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
  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
Intervention Model: Crossover Assignment
Masking: None (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 ]

Secondary Outcome Measures:
  • Safety: Incidence of adverse events [ Time Frame: approximately 2 months ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01612143


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

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01612143     History of Changes
Other Study ID Numbers: NP28327
2012-001001-24 ( EudraCT Number )
First Submitted: June 1, 2012
First Posted: June 5, 2012
Last Update Posted: November 2, 2016
Last Verified: November 2016