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

NCT00860275 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2011-01-25

No results posted yet for this study

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

Conditions

  • Alzheimer Disease

Interventions

DRUG

BMS-708163

Capsule, Oral, 50 mg, once, Day 1

DRUG

BMS-708163 + Ketoconazole

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

DRUG

Ketoconazole

Tablet, Oral, 400 mg, daily, 16 days

DRUG

Fluconazole

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

DRUG

BMS-708163 + Fluconazole

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

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2009-06-30
Completion
2009-06-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00860275 on ClinicalTrials.gov