Drug-Drug Interaction Study With Rifampin
Information source: Bristol-Myers Squibb
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Alzheimer Disease
Intervention: BMS-708163 (Drug); Rifampin (Drug); Rifampin (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: Bristol-Myers Squibb Official(s) and/or principal investigator(s):
Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb
Overall contact:
For participation information at a USA site use a phone number below. For site information outside the USA please email:, Email: Clinical.Trials@bms.com
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
Clinical Details
Official title: A Study of the Effect of Concomitant Administration of Rifampin on the Pharmacokinetics of BMS-708163 in Healthy Subjects
Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
Primary outcome: 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: BMS-708163 alone and with rifampin: Safety and tolerability (AE's, ECG, vital signs, safety labs)
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Healthy male and postmenopausal female subjects, 18-55 yrs old inclusive
Exclusion Criteria:
- Women of childbearing potential
- Tuberculosis
Locations and Contacts
For participation information at a USA site use a phone number below. For site information outside the USA please email:, Email: Clinical.Trials@bms.com
Local Institution, Bangalore 560100, India; Recruiting
Site 001
Additional Information
BMS Clinical Trials Disclosure Investigator Inquiry form For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
Starting date: August 2010
Last updated: October 4, 2010
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