Drug-Drug Interaction Study in Healthy Subjects

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00904059
First received: April 21, 2009
Last updated: January 6, 2011
Last verified: December 2010
  Purpose

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


Condition Intervention Phase
Hepatitis C
Drug: BMS-650032
Drug: BMS-790052
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Pharmacokinetic parameters including AUC (TAU) Cmax and Cmin [ Time Frame: Day 21 pharmacokinetic assessment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess the safety, tolerability, and fractional excretion of sodium when BMS-709952 and BMS-650032 are co-administered [ Time Frame: Within 24 hours post dose ] [ Designated as safety issue: Yes ]

Enrollment: 28
Study Start Date: May 2009
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment Group A Drug: BMS-650032
Capsules, Oral, 600 mg, Q12h, Days 1-7
Experimental: Treatment Group B Drug: BMS-790052
Capsules, Oral, 60 mg, Q24h, Days 1-7
Experimental: Treatment Group C
Treatment Groups A and B are followed by Treatment Group C: A combination of BMS-650032 (200 mg) and BMS-790052 (30 mg)
Drug: BMS-650032
Capsules, Oral, 200 mg, Q12h, Days 8-21
Drug: BMS-790052
Capsules, Oral, 30 mg, Q24h, Days 8-21

Detailed Description:

Pharmacokinetics and Safety in Healthy Subjects

  Eligibility

Ages Eligible for Study:   18 Years to 49 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00904059

Locations
United States, Texas
Ppd Development, Lp
Austin, Texas, United States, 78744
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00904059     History of Changes
Other Study ID Numbers: AI447-009
Study First Received: April 21, 2009
Last Updated: January 6, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on April 16, 2014