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A Relative Bioavailability Study of Danoprevir and Ritonavir in Healthy Volunteers

NCT ID: NCT01483729

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

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2012-01-31

Brief Summary

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This single dose, randomized, open-label, 6 sequence, 3-period, crossover study will evaluate the relative bioavailability of danoprevir and ritonavir in healthy volunteers. In Part 1, subjects will be randomized to receive single oral doses of one of three tablet formulations of danoprevir plus the reference ritonavir formulation, with an at least 7-day washout between periods. In Part 2, subjects will be randomized to receive single oral doses of one of three tablet formulations of ritonavir plus the reference formulation of danoprevir, with at least a 7-day washout betwen periods. The anticipated time on study is up to 30 days.

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

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part 1 A

Group Type ACTIVE_COMPARATOR

danoprevir

Intervention Type DRUG

Reference Phase 2 Tablet Formulation, single oral dose

ritonavir

Intervention Type DRUG

Reference Formulation, single oral dose

Part 1 B

Group Type EXPERIMENTAL

danoprevir

Intervention Type DRUG

Phase 3 Tablet Formulation 1, single oral dose

ritonavir

Intervention Type DRUG

Reference Formulation, single oral dose

Part 1 C

Group Type EXPERIMENTAL

danoprevir

Intervention Type DRUG

Phase 3 Tablet Formulation 2, single oral dose

ritonavir

Intervention Type DRUG

Reference Formulation, single oral dose

Part 2 D

Group Type ACTIVE_COMPARATOR

danoprevir

Intervention Type DRUG

Reference Phase 2 Tablet Formulation, single oral dose

ritonavir

Intervention Type DRUG

Reference Formulation, single oral dose

Part 2 E

Group Type EXPERIMENTAL

danoprevir

Intervention Type DRUG

Reference Phase 2 Tablet Formulation, single oral dose

ritonavir

Intervention Type DRUG

Test Formulation 1, single oral dose

Part 2 F

Group Type EXPERIMENTAL

danoprevir

Intervention Type DRUG

Reference Phase 2 Tablet Formulation, single oral dose

ritonavir

Intervention Type DRUG

Test Formulation 2, single oral dose

Interventions

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danoprevir

Phase 3 Tablet Formulation 1, single oral dose

Intervention Type DRUG

danoprevir

Phase 3 Tablet Formulation 2, single oral dose

Intervention Type DRUG

danoprevir

Reference Phase 2 Tablet Formulation, single oral dose

Intervention Type DRUG

ritonavir

Test Formulation 1, single oral dose

Intervention Type DRUG

ritonavir

Test Formulation 2, single oral dose

Intervention Type DRUG

ritonavir

Reference Formulation, single oral dose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy volunteers, 18 to 45 years of age inclusive
* Body mass index 18.0 - 32.0 kg/m2, weight \>/= 50 kg
* Healthy status will be defined as absence of evidence of any active or chronic disease following a detailed medical and surgical history and a complete physical examination
* Non-smoker
* Medical history without major, recent or ongoing pathology
* Females of childbearing potential and males and their female partners of childbearing potential must agree to use 2 forms of contraception (barrier form plus intrauterine device and spemicide) during the study and for 90 days after the last drug administration

Exclusion Criteria

* Pregnant or lactating women or males with female partners who are pregnant or lactating
* Positive results for drugs of abuse at screening or prior to admission to the clinical site during any study period
* Positive for hepatitis B, hepatitis C or HIV infection
* Use of hormonal contraceptives (birth control pills, injectable, implantable devices) within 30 days before the first dose of study medication
* Routine use of more than 2 g of acetaminophen daily
* History of clinically significant drug allergy (such as anaphylaxis) or hepatotoxicity
* History of hypersensitivity to danoptevir, ritonavir, or other protease inhibitors
* History (within 3 months of screening) of alcohol consumption exceeding 2 standard drinks per day on average
* Current enrollment or participation in a clinical trial of an experimental medication or medical device within 3 months of screening unless agreed upon by the Sponsor
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 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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Christchurch, , New Zealand

Site Status

Countries

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New Zealand

Other Identifiers

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RPU425UD-114254

Identifier Type: OTHER

Identifier Source: secondary_id

NP27945

Identifier Type: -

Identifier Source: org_study_id