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Completed

NCT Number: NCT01002079

Drug-Drug Interaction Study With Rifampin

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

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Key information

Conditions

Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution

Bangalore, 560100, India

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Women of childbearing potential
  • Tuberculosis

Treatment and study plan

BMS-708163

Drug

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

Rifampin

Drug

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

Primary outcomes

  1. 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 outcomes

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

    Time frame: Within 30 days after dose

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Collaborators

  • PRA Health Sciences

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Oct 27, 2009
Registry last updated
Jan 25, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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