Drug-Drug Interaction (DDI) w/Ketoconazole or Fluconazole
A Study of the Effect of Concomitant Administration of Ketoconazole or Fluconazole on the Pharmacokinetics of BMS-708163 in Healthy Subjects
1 other identifier
interventional
30
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 alzheimer-disease
Started Apr 2009
Shorter than P25 for phase_1 alzheimer-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 11, 2009
CompletedFirst Posted
Study publicly available on registry
March 12, 2009
CompletedStudy Start
First participant enrolled
April 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedJanuary 25, 2011
July 1, 2009
2 months
March 11, 2009
January 24, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
PK profile of BMS-708163
Within 14 days after dose
Secondary Outcomes (1)
Safety and tolerability of BMS-708163 when administered alone and with either ketoconazole or fluconazole
During the entire study period
Study Arms (2)
BMS-708163 / Ketoconazole
ACTIVE COMPARATORBMS-708163 / Fluconazole
ACTIVE COMPARATORInterventions
(BMS-708163) - Capsule, Oral, 50 mg, daily, 1 day Day 12 (Ketoconazole) - Tablet, Oral, 400 mg, daily, 1 day
(BMS-708163) - Capsule, Oral, 50 mg, daily, 1 day (Day 12) (Fluconazole) - Tablet, Oral, 200 mg, daily, 13 days
Eligibility Criteria
You may qualify if:
- Healthy male and postmenopausal female subjects 18-55 yrs old inclusive
You may not qualify if:
- Premenopausal women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ppd Development, Lp
Austin, Texas, 78744, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 11, 2009
First Posted
March 12, 2009
Study Start
April 1, 2009
Primary Completion
June 1, 2009
Study Completion
June 1, 2009
Last Updated
January 25, 2011
Record last verified: 2009-07