Overview

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

Status:
Completed
Trial end date:
2011-11-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Hoffmann-La Roche
Treatments:
Atazanavir Sulfate
Ketoconazole
Rifampin
Ritonavir
Criteria
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