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

Healthy Volunteer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01591850
• Other study ID #: BP27852
• Status: Completed
• Phase: Phase 1
• First received: May 3, 2012
• Last updated: November 1, 2016
• Start date: September 2011
• Est. completion date: November 2011

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• RO5093151
Single oral dose
• atazanavir
Multiple oral doses
• ketoconazole
Multiple oral doses
• rifampicin
Multiple oral doses
• ritonavir
Multiple oral doses

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part 1: Effect of multiple doses of ketoconazole on single-dose pharmacokinetics of RO5093151 and metabolites: Area under the concentration-time curve (AUC)		Pre-dose and up to 72 hours post-dose	No
Primary	Part 2: Effect of multiple doses of rifampicin on single-dose pharmacokinetics of RO5093151 and metabolites: Area under the concentration-time curve (AUC)		Pre-dose and up to 72 hours post-dose	No
Primary	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)		Pre-dose and up to 72 hours post-dose	No
Secondary	Safety: Incidence of adverse events		approximately 6 month	No
Secondary	RO5093151 metabolites: Plasma/urine concentrations		Pre-dose and up to 72 hours post-dose	No
Secondary	Pharmacodynamics: Area under the effect curve (AUEC) for plasma cortisol/cortisone (Part 1 only)		Pre-dose and up to 24 hours post-dose	No