Hepatitis C
Conditions
Brief 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
Detailed description
Pharmacokinetics and Safety in Healthy Subjects
Interventions
DRUGBMS-650032
Capsules, Oral, 600 mg, Q12h, Days 1-7
DRUGBMS-790052
Capsules, Oral, 60 mg, Q24h, Days 1-7
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 49 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters including AUC (TAU) Cmax and Cmin | Day 21 pharmacokinetic assessment |
Secondary
| Measure | Time frame |
|---|---|
| To assess the safety, tolerability, and fractional excretion of sodium when BMS-709952 and BMS-650032 are co-administered | Within 24 hours post dose |
Countries
United States
Outcome results
None listed