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

This study has been completed.
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov 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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: Yes ]

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
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

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


  • Premenopausal women
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov 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:
No publications provided

Responsible Party: Study Director, Bristol-Myers squibb
ClinicalTrials.gov Identifier: NCT00860275     History of Changes
Other Study ID Numbers: CN156-019 
Study First Received: March 11, 2009
Last Updated: January 24, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
14-alpha Demethylase Inhibitors
Anti-Infective Agents
Antifungal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on February 11, 2016