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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00860275
Recruitment Status : Completed
First Posted : March 12, 2009
Last Update Posted : January 25, 2011
Information provided by:
Bristol-Myers Squibb

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Alzheimer Disease Drug: BMS-708163 Drug: BMS-708163 + Ketoconazole Drug: Ketoconazole Drug: Fluconazole Drug: BMS-708163 + Fluconazole Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Study of the Effect of Concomitant Administration of Ketoconazole or Fluconazole on the Pharmacokinetics of BMS-708163 in Healthy Subjects
Study Start Date : April 2009
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

Arm Intervention/treatment
Active Comparator: BMS-708163 / Ketoconazole Drug: BMS-708163
Capsule, Oral, 50 mg, once, Day 1
Drug: BMS-708163 + Ketoconazole
(BMS-708163) - Capsule, Oral, 50 mg, daily, 1 day Day 12 (Ketoconazole) - Tablet, Oral, 400 mg, daily, 1 day
Drug: Ketoconazole
Tablet, Oral, 400 mg, daily, 16 days
Active Comparator: BMS-708163 / Fluconazole Drug: BMS-708163
Capsule, Oral, 50 mg, once, Day 1
Drug: Fluconazole
Tablet, Oral, 1 day 400 mg then 3 days 200 mg
Drug: BMS-708163 + Fluconazole
(BMS-708163) - Capsule, Oral, 50 mg, daily, 1 day (Day 12) (Fluconazole) - Tablet, Oral, 200 mg, daily, 13 days

Primary Outcome Measures :
  1. PK profile of BMS-708163 [ Time Frame: Within 14 days after dose ]

Secondary Outcome Measures :
  1. Safety and tolerability of BMS-708163 when administered alone and with either ketoconazole or fluconazole [ Time Frame: During the entire study period ]

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

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


  • Premenopausal women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00860275

United States, Texas
Ppd Development, Lp
Austin, Texas, United States, 78744
Sponsors and Collaborators
Bristol-Myers Squibb
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Responsible Party: Study Director, Bristol-Myers squibb Identifier: NCT00860275     History of Changes
Other Study ID Numbers: CN156-019
First Posted: March 12, 2009    Key Record Dates
Last Update Posted: January 25, 2011
Last Verified: July 2009

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors