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

This study has been completed.
Information provided by:
Bristol-Myers Squibb Identifier:
First received: March 11, 2009
Last updated: January 24, 2011
Last verified: July 2009
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 Intervention Phase
Alzheimer Disease Drug: BMS-708163 Drug: BMS-708163 + Ketoconazole Drug: Ketoconazole Drug: Fluconazole Drug: BMS-708163 + Fluconazole Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Bristol-Myers Squibb:

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

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

Enrollment: 30
Study Start Date: April 2009
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

Additional Information:
Responsible Party: Study Director, Bristol-Myers squibb Identifier: NCT00860275     History of Changes
Other Study ID Numbers: CN156-019
Study First Received: March 11, 2009
Last Updated: January 24, 2011

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 processed this record on September 18, 2017