Drug Interaction Study

• Status: Completed
• Trial end date: 2008-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the exposure of rifabutin (RIB) when administered with atazanavir and ritonavir (ATV/RTV)

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Atazanavir Sulfate; Rifabutin; Ritonavir

Criteria

Inclusion Criteria:

• Healthy male and female subjects between the ages of 18 to 50 years old with a body mass index (BMI) of 18 to 32 kg/m²

• Prior to enrollment, subjects must have physical and laboratory test findings within the normal limits, and women of childbearing potential (WOCBP) must have a negative pregnancy test

Exclusion Criteria:

• Any significant acute or chronic medical illness

• Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, electrocardiogram (ECG) or clinical laboratory determinations

• Use of any prescription drugs or over-the-counter acid controllers within 4 weeks prior to study drug administration

• Use of any other drugs, including over-the-counter medications of herbal preparations within 1 week prior to study drug administration