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Completed

NCT Number: NCT01612143

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

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.

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Key information

Conditions

Healthy Volunteer

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Zuidlaren, 9471 GP, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

setrobuvir

Drug

200 mg capsule formulation, single oral dose

Primary outcomes

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

    Time frame: Pre-dose and up to 168 hours post-dose

Secondary outcomes

  1. Safety: Incidence of adverse events

    Time frame: approximately 2 months

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jun 5, 2012
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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