A Drug-Drug Interaction Study of Ketoconazole, Rifampicin and Ritonavir-Boosted Atazanavir With Single-Dose RO5093151 in Healthy Volunteers
This study has been completed.
Sponsor:
Hoffmann-La Roche
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01591850
First received: May 3, 2012
Last updated: NA
Last verified: May 2012
History: No changes posted
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy Volunteer |
Drug: RO5093151 Drug: ketoconazole Drug: rifampicin Drug: atazanavir Drug: ritonavir |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Parallel Assignment Masking: Open Label |
| 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 |
Resource links provided by NLM:
Further study details as provided by Hoffmann-La Roche:
Primary Outcome Measures:
- Part 1: Effect of multiple doses of ketoconazole on single-dose pharmacokinetics of RO5093151 and metabolites: Area under the concentration-time curve (AUC) [ Time Frame: Pre-dose and up to 72 hours post-dose ] [ Designated as safety issue: No ]
- Part 2: Effect of multiple doses of rifampicin on single-dose pharmacokinetics of RO5093151 and metabolites: Area under the concentration-time curve (AUC) [ Time Frame: Pre-dose and up to 72 hours post-dose ] [ Designated as safety issue: No ]
- 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) [ Time Frame: Pre-dose and up to 72 hours post-dose ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Safety: Incidence of adverse events [ Time Frame: approximately 6 month ] [ Designated as safety issue: No ]
- RO5093151 metabolites: Plasma/urine concentrations [ Time Frame: Pre-dose and up to 72 hours post-dose ] [ Designated as safety issue: No ]
- Pharmacodynamics: Area under the effect curve (AUEC) for plasma cortisol/cortisone (Part 1 only) [ Time Frame: Pre-dose and up to 24 hours post-dose ] [ Designated as safety issue: No ]
| Enrollment: | 51 |
| Study Start Date: | September 2011 |
| Study Completion Date: | April 2012 |
| Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 Ketoconazole DDI |
Drug: RO5093151
Single oral dose
Drug: ketoconazole
Multiple oral doses
|
| Experimental: 2 Rifampicin DDI |
Drug: RO5093151
Single oral dose
Drug: rifampicin
Multiple oral doses
|
| Experimental: 3 ATZ/r DDI |
Drug: RO5093151
Single oral dose
Drug: atazanavir
Multiple oral doses
Drug: ritonavir
Multiple oral doses
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations More Information
No publications provided
| Responsible Party: | Disclosures Group, Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT01591850 History of Changes |
| Other Study ID Numbers: | BP27852 |
| Study First Received: | May 3, 2012 |
| Last Updated: | May 3, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Ketoconazole Atazanavir Rifampin Ritonavir 14-alpha Demethylase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antifungal Agents Anti-Infective Agents Therapeutic Uses |
Antibiotics, Antitubercular Anti-Bacterial Agents Antitubercular Agents Leprostatic Agents Nucleic Acid Synthesis Inhibitors HIV Protease Inhibitors Protease Inhibitors Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents |
ClinicalTrials.gov processed this record on May 19, 2013