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OpenTrials
Completed

NCT Number: NCT00860275

Drug-Drug Interaction (DDI) w/Ketoconazole or Fluconazole

The purpose of the study is to determine if the concomitant administration of either ketoconazole or fluconazole with BMS-708163 will affect the PK of BMS-708163 and to assess safety and tolerability of BMS-708163

Completed

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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

Ppd Development, Lp

Austin, Texas, 78744, United States

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:

  • Premenopausal women

Treatment and study plan

BMS-708163

Drug

Capsule, Oral, 50 mg, once, Day 1

BMS-708163 + Ketoconazole

Drug

(BMS-708163) - Capsule, Oral, 50 mg, daily, 1 day Day 12 (Ketoconazole) - Tablet, Oral, 400 mg, daily, 1 day

Ketoconazole

Drug

Tablet, Oral, 400 mg, daily, 16 days

Fluconazole

Drug

Tablet, Oral, 1 day 400 mg then 3 days 200 mg

BMS-708163 + Fluconazole

Drug

(BMS-708163) - Capsule, Oral, 50 mg, daily, 1 day (Day 12) (Fluconazole) - Tablet, Oral, 200 mg, daily, 13 days

Primary outcomes

  1. PK profile of BMS-708163

    Time frame: Within 14 days after dose

Secondary outcomes

  1. Safety and tolerability of BMS-708163 when administered alone and with either ketoconazole or fluconazole

    Time frame: During the entire study period

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A Study of the Effect of Concomitant Administration of Ketoconazole or Fluconazole on the Pharmacokinetics of BMS-708163 in Healthy Subjects

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Mar 12, 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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