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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Alzheimer Disease

Treatments: Drug: Ketoconazole; Drug: Fluconazole; Drug: BMS-708163; Drug: BMS-708163 + Ketoconazole; Drug: BMS-708163 + Fluconazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT00860275

CN156-019

Details and patient eligibility

About

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

Enrollment: 30 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

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

Exclusion:

• Premenopausal women

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

BMS-708163 / Ketoconazole

Active Comparator group

Treatment:

Drug: BMS-708163

Drug: Ketoconazole

Drug: BMS-708163 + Ketoconazole

BMS-708163 / Fluconazole

Active Comparator group

Treatment:

Drug: Fluconazole

Drug: BMS-708163

Drug: BMS-708163 + Fluconazole