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Drug-Drug Interaction Study With Rifampin

Primary Purpose

Alzheimer Disease

Status
Completed
Phase
Phase 1
Locations
India
Study Type
Interventional
Intervention
BMS-708163
Rifampin
Rifampin
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Alzheimer Disease

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Women of childbearing potential
  • Tuberculosis

Sites / Locations

  • Local Institution

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Other

Experimental

Arm Label

BMS-708163

Rifampin

Rifampin + BMS-708163

Arm Description

Outcomes

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)

Secondary Outcome Measures

BMS-708163 alone and with rifampin: Safety and tolerability (AE's, ECG, vital signs, safety labs)

Full Information

First Posted
October 26, 2009
Last Updated
January 24, 2011
Sponsor
Bristol-Myers Squibb
Collaborators
PRA Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01002079
Brief Title
Drug-Drug Interaction Study With Rifampin
Official Title
A Study of the Effect of Concomitant Administration of Rifampin on the Pharmacokinetics of BMS-708163 in Healthy Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Bristol-Myers Squibb
Collaborators
PRA Health Sciences

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BMS-708163
Arm Type
Experimental
Arm Title
Rifampin
Arm Type
Other
Arm Title
Rifampin + BMS-708163
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
BMS-708163
Intervention Description
Capsule, Oral, 125 mg, Once daily, 1 day
Intervention Type
Drug
Intervention Name(s)
Rifampin
Intervention Description
Capsule, Oral, 600 mg, Once daily, 7 days
Intervention Type
Drug
Intervention Name(s)
Rifampin
Intervention Description
Capsule, Oral, 600 mg, Once daily, 6 days
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
BMS-708163 alone and with rifampin: Safety and tolerability (AE's, ECG, vital signs, safety labs)
Time Frame
Within 30 days after dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy male and postmenopausal female subjects, 18-55 yrs old inclusive Exclusion Criteria: Women of childbearing potential Tuberculosis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution
City
Bangalore
ZIP/Postal Code
560100
Country
India

12. IPD Sharing Statement

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Drug-Drug Interaction Study With Rifampin

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