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:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01591850
First received: May 3, 2012
Last updated: August 26, 2014
Last verified: August 2014
  Purpose

This randomized, single-center, open-label, one-sequence, two-period crossover s tudy in three parts will assess the effects of multiple doses of ketoconazole, r ifampicin and ritonavir-boosted atazanavir on the pharmacokinetics of a single d ose of RO5093151 in healthy male and female volunteers. In Period 1, subjects wi ll 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, r ifampicin or ritonavir-boosted atazanavir. Anticipated time on study is up to 8.

5 weeks.


Condition Intervention Phase
Healthy Volunteer
Drug: RO5093151
Drug: atazanavir
Drug: ketoconazole
Drug: rifampicin
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: November 2011
Primary Completion Date: November 2011 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01591850

Locations
United States, Florida
Merritt Island, Florida, United States, 32953
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01591850     History of Changes
Other Study ID Numbers: BP27852
Study First Received: May 3, 2012
Last Updated: August 26, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Ketoconazole
Atazanavir
Rifampin
Ritonavir
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
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 August 28, 2014