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

Roche

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: rifampicin; Drug: ketoconazole; Drug: ritonavir; Drug: RO5093151; Drug: atazanavir

Study type: Interventional

Funder types: Industry

Identifiers

NCT01591850

BP27852

Details and patient eligibility

About

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.

Enrollment: 51 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

51 participants in 3 patient groups

1 Ketoconazole DDI

Experimental group

Treatment:

Drug: RO5093151

Drug: ketoconazole

2 Rifampicin DDI

Experimental group

Treatment:

Drug: RO5093151

Drug: rifampicin

3 ATZ/r DDI

Experimental group

Treatment:

Drug: atazanavir

Drug: RO5093151

Drug: ritonavir