Drug-Drug Interaction Study in Healthy Subjects

Hepatitis C Clinical Trial

Official title:

Open-Label, Randomized, Multiple-Dose, Drug-Drug Interaction Study to Assess the Pharmacokinetics and Safety of BMS-790052 and BMS-650032 Co-administered in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00904059
• Other study ID #: AI447-009
• Status: Completed
• Phase: Phase 1
• First received: April 21, 2009
• Last updated: January 6, 2011
• Start date: May 2009
• Est. completion date: July 2009

Study information

• Verified date: December 2010
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Description:

Pharmacokinetics and Safety in Healthy Subjects

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 49 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Hepatitis C

Intervention

Drug:
• BMS-650032
Capsules, Oral, 600 mg, Q12h, Days 1-7
• BMS-790052
Capsules, Oral, 60 mg, Q24h, Days 1-7
• BMS-650032
Capsules, Oral, 200 mg, Q12h, Days 8-21
• BMS-790052
Capsules, Oral, 30 mg, Q24h, Days 8-21

Locations

Country	Name	City	State
United States	Ppd Development, Lp	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetic parameters including AUC (TAU) Cmax and Cmin		Day 21 pharmacokinetic assessment	No
Secondary	To assess the safety, tolerability, and fractional excretion of sodium when BMS-709952 and BMS-650032 are co-administered		Within 24 hours post dose	Yes

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
•   Investigator Inquiry form