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

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00860275
First received: March 11, 2009
Last updated: January 24, 2011
Last verified: July 2009
  Purpose

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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion:

  • 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 ClinicalTrials.gov identifier: NCT00860275

Locations
United States, Texas
Ppd Development, Lp
Austin, Texas, United States, 78744
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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
Dementia
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Tauopathies
Fluconazole
Ketoconazole
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 March 02, 2015