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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01002079

Enrollment

Registered

2009-10-27

Start date

2010-08-31

Completion date

2010-10-31

Last updated

2011-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease

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

Interventions

DRUGBMS-708163

Capsule, Oral, 125 mg, Once daily, 1 day

DRUGRifampin

Capsule, Oral, 600 mg, Once daily, 7 days

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

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

Exclusion criteria

* Women of childbearing potential * Tuberculosis

Design outcomes

Primary

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

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

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026