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A Drug-Drug Interaction Study of Ketoconazole, Rifampicin and Ritonavir-Boosted Atazanavir With Single-Dose RO5093151 in Healthy Volunteers

NCT ID: NCT01591850

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

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2011-11-30

Brief Summary

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This randomized, single-center, open-label, one-sequence, two-period crossover study in three parts will assess the effects of multiple doses of ketoconazole, rifampicin and ritonavir-boosted atazanavir on the pharmacokinetics of a single dose of RO5093151 in healthy male and female volunteers. In Period 1, subjects will receive a single oral dose of RO5093151. In Period 2, subjects will receive a single oral dose of RO5093151 and multiple oral doses of either ketoconazole, rifampicin or ritonavir-boosted atazanavir. Anticipated time on study is up to 8.5 weeks.

Detailed Description

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Conditions

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Healthy Volunteer

Study Design

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Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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1 Ketoconazole DDI

Group Type EXPERIMENTAL

RO5093151

Intervention Type DRUG

Single oral dose

ketoconazole

Intervention Type DRUG

Multiple oral doses

2 Rifampicin DDI

Group Type EXPERIMENTAL

RO5093151

Intervention Type DRUG

Single oral dose

rifampicin

Intervention Type DRUG

Multiple oral doses

3 ATZ/r DDI

Group Type EXPERIMENTAL

RO5093151

Intervention Type DRUG

Single oral dose

atazanavir

Intervention Type DRUG

Multiple oral doses

ritonavir

Intervention Type DRUG

Multiple oral doses

Interventions

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RO5093151

Single oral dose

Intervention Type DRUG

atazanavir

Multiple oral doses

Intervention Type DRUG

ketoconazole

Multiple oral doses

Intervention Type DRUG

rifampicin

Multiple oral doses

Intervention Type DRUG

ritonavir

Multiple oral doses

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male and female subjects, 18 to 65 years of age. Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history and complete physical examination
* Body mass index (BMI) 18 to 30 kg/m2
* Females of child-bearing potential must agree to use two effective methods of contraception, including a barrier method and an intrauterine non-hormonal device (set in place at least 3 months before first dosing) for the duration of the study and at least 1 month after last dosing
* Non-smoker for at least 90 days prior to screening

Exclusion Criteria

* Pregnant or lactating females
* History of drug abuse in the past 2 years, or suspicion of regular consumption of drugs of abuse, or positive result on drugs of abuse test
* History of alcoholism in the past 2 years, or positive alcohol test
* Positive for hepatitis B, hepatitis C or HIV infection
* Systemic , topical, intranasal or inhaled corticosteroid therapy for more than 2 weeks within 3 months prior to screening
* Participation in an investigational drug or device study within 90 days prior to screening
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 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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Merritt Island, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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BP27852

Identifier Type: -

Identifier Source: org_study_id