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

Information source: Hoffmann-La Roche
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy Volunteer

Intervention: RO5093151 (Drug); atazanavir (Drug); ketoconazole (Drug); rifampicin (Drug); ritonavir (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Hoffmann-La Roche

Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche

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.

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label

Primary outcome:

Part 1: Effect of multiple doses of ketoconazole on single-dose pharmacokinetics of RO5093151 and metabolites: Area under the concentration-time curve (AUC)

Part 2: Effect of multiple doses of rifampicin on single-dose pharmacokinetics of RO5093151 and metabolites: Area under the concentration-time curve (AUC)

Part 3: Effect of multiple doses of ritonavir-boosted atazanavir on single-dose pharmacokinetics of RO5093151 and metabolites: Area under the concentration-time curve (AUC)

Secondary outcome:

Safety: Incidence of adverse events

RO5093151 metabolites: Plasma/urine concentrations

Pharmacodynamics: Area under the effect curve (AUEC) for plasma cortisol/cortisone (Part 1 only)

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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

Locations and Contacts

Merritt Island, Florida 32953, United States
Additional Information

Starting date: September 2011
Last updated: August 17, 2015

Page last updated: August 23, 2015

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