Drug-Drug Interaction Study in Healthy Subjects

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Hepatitis C

Treatments: Drug: BMS-650032; Drug: BMS-790052

Study type: Interventional

Funder types: Industry

Identifiers

NCT00904059

AI447-009

Details and patient eligibility

About

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

Full description

Pharmacokinetics and Safety in Healthy Subjects

Enrollment: 28 patients

Sex: All

Ages: 18 to 49 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

28 participants in 3 patient groups

Treatment Group A

Experimental group

Treatment:

Drug: BMS-650032

Drug: BMS-650032

Treatment Group B

Experimental group

Treatment:

Drug: BMS-790052

Drug: BMS-790052

Treatment Group C

Experimental group

Description:

Treatment Groups A and B are followed by Treatment Group C: A combination of BMS-650032 (200 mg) and BMS-790052 (30 mg)

Treatment:

Drug: BMS-790052

Drug: BMS-790052

Drug: BMS-650032

Drug: BMS-650032