Drug-Drug Interaction Study With Rifampin
Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Completed
CT.gov ID
NCT01002079
Collaborator
PRA Health Sciences (Industry)
20
1
3
2
10
Study Details
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
20 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (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
Study Start Date
:
Aug 1, 2010
Actual Primary Completion Date
:
Oct 1, 2010
Actual Study Completion Date
:
Oct 1, 2010
Arms and Interventions
| 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
|
| 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
|
Outcome Measures
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) [Within 30 days after dose]
Secondary Outcome Measures
- BMS-708163 alone and with rifampin: Safety and tolerability (AE's, ECG, vital signs, safety labs) [Within 30 days after dose]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
- Healthy male and postmenopausal female subjects, 18-55 yrs old inclusive
Exclusion Criteria:
-
Women of childbearing potential
-
Tuberculosis
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Local Institution | Bangalore | India | 560100 |
Sponsors and Collaborators
- Bristol-Myers Squibb
- PRA Health Sciences
Investigators
- Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT01002079
Other Study ID Numbers:
- CN156-028
First Posted:
Oct 27, 2009
Last Update Posted:
Jan 25, 2011
Last Verified:
Nov 1, 2010