Drug-Drug Interaction Study With Rifampin

Alzheimer Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01002079
• Other study ID #: CN156-028
• Status: Completed
• Phase: Phase 1
• First received: October 26, 2009
• Last updated: January 24, 2011
• Start date: August 2010
• Est. completion date: October 2010

Study information

• Verified date: November 2010
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Ministry of HealthIndia: Central Drugs Standard Control Organization
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Women of childbearing potential

• Tuberculosis

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Drug:
• BMS-708163
Capsule, Oral, 125 mg, Once daily, 1 day
• Rifampin
Capsule, Oral, 600 mg, Once daily, 7 days
• Rifampin
Capsule, Oral, 600 mg, Once daily, 6 days

Locations

Country	Name	City	State
India	Local Institution	Bangalore

Sponsors (2)

Lead Sponsor	Collaborator
Bristol-Myers Squibb	PRA Health Sciences

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	BMS-708163 alone and with rifampin: Safety and tolerability (AE's, ECG, vital signs, safety labs)		Within 30 days after dose	Yes

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
•   Investigator Inquiry form