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

Phase 1

Completed

• Conditions: Alzheimer Disease
• Interventions: Drug: BMS-708163; Drug: BMS-708163 + Ketoconazole; Drug: Fluconazole; Drug: Ketoconazole; Drug: BMS-708163 + Fluconazole

• Registration Number: NCT00860275
• Lead Sponsor: Bristol-Myers Squibb

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-03-11
• Study First Submitted QC: 2009-03-11
• Study First Posted: 2009-03-12
• Study Start: 2009-04
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Status Verified: 2009-07
• Last Update Submitted: 2011-01-24
• Last Update Posted: 2011-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

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

Exclusion:

• Premenopausal women

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BMS-708163 / Ketoconazole	BMS-708163	-
BMS-708163 / Ketoconazole	BMS-708163 + Ketoconazole	-
BMS-708163 / Ketoconazole	Ketoconazole	-
BMS-708163 / Fluconazole	BMS-708163	-
BMS-708163 / Fluconazole	BMS-708163 + Fluconazole	-
BMS-708163 / Fluconazole	Fluconazole	-

Primary Outcome Measures

Name	Time	Method
PK profile of BMS-708163	Within 14 days after dose

Secondary Outcome Measures

Name	Time	Method
Safety and tolerability of BMS-708163 when administered alone and with either ketoconazole or fluconazole	During the entire study period

Trial Locations

Locations (1)

Ppd Development, Lp; 🇺🇸 Austin, Texas, United States