Drug-Drug Interaction Study in Healthy Subjects

• Status: Completed
• Trial end date: 2009-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the pharmacokinetics and safety of BMS-790052 and BMS-650032 when co-administered and when administered alone

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

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Asunaprevir

Criteria

Inclusion Criteria:

• Healthy male and female subjects aged 18 to 49 years

• Females who are not of childbearing potential, pregnant or breastfeeding

• Subject Body Mass Index (BMI) of 18 to 32 kg/m²

Exclusion Criteria:

• Women of child bearing potential

• Male subjects who have sex with women who are unwilling to agree to practice male barrier contraception during study participation and for a least 12 weeks following dosing

• Any significant acute or chronic medical illness

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

• Prior exposure to BMS-650032 or BMS-790052

• Positive for HIV or HCV