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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014