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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00860275

Enrollment

Registered

2009-03-12

Start date

2009-04-30

Completion date

2009-06-30

Last updated

2011-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease

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

Interventions

DRUGBMS-708163

Capsule, Oral, 50 mg, once, Day 1

DRUGBMS-708163 + Ketoconazole

(BMS-708163) - Capsule, Oral, 50 mg, daily, 1 day Day 12 (Ketoconazole) - Tablet, Oral, 400 mg, daily, 1 day

DRUGKetoconazole

Tablet, Oral, 400 mg, daily, 16 days

DRUGFluconazole

Tablet, Oral, 1 day 400 mg then 3 days 200 mg

DRUGBMS-708163 + Fluconazole

(BMS-708163) - Capsule, Oral, 50 mg, daily, 1 day (Day 12) (Fluconazole) - Tablet, Oral, 200 mg, daily, 13 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy male and postmenopausal female subjects 18-55 yrs old inclusive Exclusion: * Premenopausal women

Design outcomes

Primary

Measure	Time frame
PK profile of BMS-708163	Within 14 days after dose

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026