Back to resultsDrug-Drug Interaction (DDI) w/Ketoconazole or Fluconazole
Primary Purpose
Alzheimer Disease
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
BMS-708163
BMS-708163 + Ketoconazole
Ketoconazole
Fluconazole
BMS-708163 + Fluconazole
Sponsored by
About this trial
This is an interventional basic science trial for Alzheimer Disease
Eligibility Criteria
Inclusion Criteria:
- Healthy male and postmenopausal female subjects 18-55 yrs old inclusive
Exclusion:
- Premenopausal women
Sites / Locations
- Ppd Development, Lp
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
BMS-708163 / Ketoconazole
BMS-708163 / Fluconazole
Arm Description
Outcomes
Primary Outcome Measures
PK profile of BMS-708163
Secondary Outcome Measures
Safety and tolerability of BMS-708163 when administered alone and with either ketoconazole or fluconazole
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00860275
Brief Title
Drug-Drug Interaction (DDI) w/Ketoconazole or Fluconazole
Official Title
A Study of the Effect of Concomitant Administration of Ketoconazole or Fluconazole on the Pharmacokinetics of BMS-708163 in Healthy Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Bristol-Myers Squibb
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BMS-708163 / Ketoconazole
Arm Type
Active Comparator
Arm Title
BMS-708163 / Fluconazole
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
BMS-708163
Intervention Description
Capsule, Oral, 50 mg, once, Day 1
Intervention Type
Drug
Intervention Name(s)
BMS-708163 + Ketoconazole
Intervention Description
(BMS-708163) - Capsule, Oral, 50 mg, daily, 1 day Day 12 (Ketoconazole) - Tablet, Oral, 400 mg, daily, 1 day
Intervention Type
Drug
Intervention Name(s)
Ketoconazole
Intervention Description
Tablet, Oral, 400 mg, daily, 16 days
Intervention Type
Drug
Intervention Name(s)
Fluconazole
Intervention Description
Tablet, Oral, 1 day 400 mg then 3 days 200 mg
Intervention Type
Drug
Intervention Name(s)
BMS-708163 + Fluconazole
Intervention Description
(BMS-708163) - Capsule, Oral, 50 mg, daily, 1 day (Day 12) (Fluconazole) - Tablet, Oral, 200 mg, daily, 13 days
Primary Outcome Measure Information:
Title
PK profile of BMS-708163
Time Frame
Within 14 days after dose
Secondary Outcome Measure Information:
Title
Safety and tolerability of BMS-708163 when administered alone and with either ketoconazole or fluconazole
Time Frame
During the entire study period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy male and postmenopausal female subjects 18-55 yrs old inclusive
Exclusion:
Premenopausal women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Ppd Development, Lp
City
Austin
State/Province
Texas
ZIP/Postal Code
78744
Country
United States
12. IPD Sharing Statement
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Drug-Drug Interaction (DDI) w/Ketoconazole or Fluconazole
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