Drug-Drug Interaction Study With Rifampin

This study has been completed.
Sponsor:
Collaborator:
PRA Health Sciences
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
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: NCT01002079

Locations
India
Local Institution
Bangalore, India, 560100
Sponsors and Collaborators
Bristol-Myers Squibb
PRA Health Sciences
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
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Dementia
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Tauopathies
Rifampin
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antitubercular
Antitubercular Agents
Enzyme Inhibitors
Leprostatic Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014