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

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. Identifier: NCT01612143
Recruitment Status : Completed
First Posted : June 5, 2012
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
Hoffmann-La Roche

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.

Condition or disease Intervention/treatment Phase
Healthy Volunteer Drug: setrobuvir Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
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
Study Start Date : June 2012
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Relative bioavailability: Cmax/area under the concentration-time curve (AUC) [ Time Frame: Pre-dose and up to 168 hours post-dose ]

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

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

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

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 identifier (NCT number): NCT01612143

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

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