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

NCT ID: NCT00860275

Last Updated: 2011-01-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2009-06-30

Brief Summary

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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

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Detailed Description

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Conditions

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Alzheimer Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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BMS-708163 / Ketoconazole

Group Type ACTIVE_COMPARATOR

BMS-708163

Intervention Type DRUG

Capsule, Oral, 50 mg, once, Day 1

BMS-708163 + Ketoconazole

Intervention Type DRUG

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

Ketoconazole

Intervention Type DRUG

Tablet, Oral, 400 mg, daily, 16 days

BMS-708163 / Fluconazole

Group Type ACTIVE_COMPARATOR

BMS-708163

Intervention Type DRUG

Capsule, Oral, 50 mg, once, Day 1

Fluconazole

Intervention Type DRUG

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

BMS-708163 + Fluconazole

Intervention Type DRUG

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

Interventions

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BMS-708163

Capsule, Oral, 50 mg, once, Day 1

Intervention Type DRUG

BMS-708163 + Ketoconazole

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

Intervention Type DRUG

Ketoconazole

Tablet, Oral, 400 mg, daily, 16 days

Intervention Type DRUG

Fluconazole

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

Intervention Type DRUG

BMS-708163 + Fluconazole

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion:

* Premenopausal women
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Bristol-Myers squibb

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Ppd Development, Lp

Austin, Texas, United States

Site Status

Countries

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United States

Related Links

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http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx

Investigator Inquiry form

Other Identifiers

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CN156-019

Identifier Type: -

Identifier Source: org_study_id

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