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

NCT ID: NCT01612143

Last Updated: 2016-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2012-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy Volunteer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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A: STV capsule (after high fat meal)

Group Type ACTIVE_COMPARATOR

setrobuvir

Intervention Type DRUG

200 mg capsule formulation, single oral dose

B: STV capsule (fasted state)

Group Type ACTIVE_COMPARATOR

setrobuvir

Intervention Type DRUG

200 mg capsule formulation, single oral dose

C: STV tablet (after high fat meal)

Group Type EXPERIMENTAL

setrobuvir

Intervention Type DRUG

200 mg tablet formulation, single oral dose

D: STV tablet (fasted state)

Group Type EXPERIMENTAL

setrobuvir

Intervention Type DRUG

200 mg tablet formulation, single oral dose

Interventions

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setrobuvir

200 mg capsule formulation, single oral dose

Intervention Type DRUG

setrobuvir

200 mg tablet formulation, single oral dose

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Zuidlaren, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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2012-001001-24

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

NP28327

Identifier Type: -

Identifier Source: org_study_id