Drug-Drug Interaction Study With Rifampin

A Study of the Effect of Concomitant Administration of Rifampin on the Pharmacokinetics of BMS-708163 in Healthy Subjects

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

Study Overview

• Status: Completed
• Conditions: Alzheimer Disease
• Intervention / Treatment: Drug: BMS-708163; Drug: Rifampin; Drug: Rifampin

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 1

Contacts and Locations

Study Locations

• India
  • Bangalore, India, 560100
    • Local Institution

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Women of childbearing potential
• Tuberculosis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BMS-708163	Drug: BMS-708163; Capsule, Oral, 125 mg, Once daily, 1 day
Other: Rifampin	Drug: Rifampin; Capsule, Oral, 600 mg, Once daily, 7 days; Drug: Rifampin; Capsule, Oral, 600 mg, Once daily, 6 days
Experimental: Rifampin + BMS-708163	Drug: BMS-708163; Capsule, Oral, 125 mg, Once daily, 1 day; Drug: Rifampin; Capsule, Oral, 600 mg, Once daily, 7 days; Drug: Rifampin; Capsule, Oral, 600 mg, Once daily, 6 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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)	Within 30 days after dose

Secondary Outcome Measures

Outcome Measure	Time Frame
BMS-708163 alone and with rifampin: Safety and tolerability (AE's, ECG, vital signs, safety labs)	Within 30 days after dose

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Collaborators: PRA Health Sciences

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Actual): October 1, 2010
• Study Completion (Actual): October 1, 2010

Study Registration Dates

• First Submitted: October 26, 2009
• First Submitted That Met QC Criteria: October 26, 2009
• First Posted (Estimate): October 27, 2009

Study Record Updates

• Last Update Posted (Estimate): January 25, 2011
• Last Update Submitted That Met QC Criteria: January 24, 2011
• Last Verified: November 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-Bacterial Agents; Leprostatic Agents; Cytochrome P-450 Enzyme Inducers; Cytochrome P-450 CYP3A Inducers; Antitubercular Agents; Antibiotics, Antitubercular; Cytochrome P-450 CYP2B6 Inducers; Cytochrome P-450 CYP2C8 Inducers; Cytochrome P-450 CYP2C19 Inducers; Cytochrome P-450 CYP2C9 Inducers; Rifampin
• Other Study ID Numbers: CN156-028

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No