A Drug-Drug Interaction Study of Ketoconazole, Rifampicin and Ritonavir-Boosted Atazanavir With Single-Dose RO5093151 in Healthy Volunteers
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 8/3/2016 |
| Start Date: | September 2011 |
| End Date: | November 2011 |
A Randomized, Single-center, Open-label, One-sequence, Two-period Crossover Study in 3 Parts to Investigate the Effects of Multiple Doses of Ketoconazole (Part 1), Rifampicin (Part 2), and Ritonavir-boosted Atazanavir (Part 3) on the PK of a Single Dose of RO5093151 in Healthy Female & Male Subjects
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.
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.
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
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