Clinical trial NCT01591850: A Drug-Drug Interaction Study of Ketoconazole, Rifampicin and Ritonavir-Boosted Atazanavir With Single-Dose RO5093151 in Healthy Volunteers
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-05-04
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Intervention model: PARALLEL

Brief 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.


Eligibility 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

Primary outcomes:
measure: Part 1: Effect of multiple doses of ketoconazole on single-dose pharmacokinetics of RO5093151 and metabolites: Area under the concentration-time curve (AUC)
timeFrame: Pre-dose and up to 72 hours post-dose
measure: Part 2: Effect of multiple doses of rifampicin on single-dose pharmacokinetics of RO5093151 and metabolites: Area under the concentration-time curve (AUC)
timeFrame: Pre-dose and up to 72 hours post-dose
measure: 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)
timeFrame: Pre-dose and up to 72 hours post-dose
Secondary outcomes:
measure: Safety: Incidence of adverse events
timeFrame: approximately 6 month
measure: RO5093151 metabolites: Plasma/urine concentrations
timeFrame: Pre-dose and up to 72 hours post-dose
measure: Pharmacodynamics: Area under the effect curve (AUEC) for plasma cortisol/cortisone (Part 1 only)
timeFrame: Pre-dose and up to 24 hours post-dose
Other outcomes:
Locations:
city: Merritt Island
country: United States
state: Florida
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: