Drug-Drug Interaction Study With Rifampin

This study has been completed.
Sponsor:
Collaborator:
PRA International
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01002079
First received: October 26, 2009
Last updated: January 24, 2011
Last verified: November 2010
  Purpose

The purpose of the study is to determine if the concomitant administration of rifampin with BMS-708163 will affect the Pharmacokinetics of BMS-708163 and to assess safety and tolerability of co-administration BMS-708163 and rifampin


Condition Intervention Phase
Alzheimer Disease
Drug: BMS-708163
Drug: Rifampin
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: A Study of the Effect of Concomitant Administration of Rifampin on the Pharmacokinetics of BMS-708163 in Healthy Subjects

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • BMS-708163 alone and with rifampin: BMS-708163 single dose PK parameters (Cmax, Tmax, T-HALF, AUC(0-T), AUC(INF), CLT/F and molar AUCmet/AUCparent ratios will be assessed without rifampin (Day 1) and with rifampin (Day 13) [ Time Frame: Within 30 days after dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • BMS-708163 alone and with rifampin: Safety and tolerability (AE's, ECG, vital signs, safety labs) [ Time Frame: Within 30 days after dose ] [ Designated as safety issue: Yes ]

Enrollment: 20
Study Start Date: August 2010
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BMS-708163 Drug: BMS-708163
Capsule, Oral, 125 mg, Once daily, 1 day
Rifampin Drug: Rifampin
Capsule, Oral, 600 mg, Once daily, 7 days
Experimental: Rifampin + BMS-708163 Drug: BMS-708163
Capsule, Oral, 125 mg, Once daily, 1 day
Drug: Rifampin
Capsule, Oral, 600 mg, Once daily, 6 days

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male and postmenopausal female subjects, 18-55 yrs old inclusive

Exclusion Criteria:

  • Women of childbearing potential
  • Tuberculosis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01002079

Locations
India
Local Institution
Bangalore, India, 560100
Sponsors and Collaborators
Bristol-Myers Squibb
PRA International
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: NCT01002079     History of Changes
Other Study ID Numbers: CN156-028
Study First Received: October 26, 2009
Last Updated: January 24, 2011
Health Authority: India: Ministry of Health
India: Central Drugs Standard Control Organization

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Rifampin
Antibiotics, Antitubercular
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Leprostatic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on April 22, 2014