Drug Interaction Study With a Potential Alzheimer's Disease Compound

Bristol-Myers Squibb22 enrolled

Overview

The purpose of this study is to determine whether BMS-708163 will effect the pharmacokinetics of the commonly prescribed medicines midazolam, warfarin, caffeine,omeprazole and dextromethorphan

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Alzheimer Disease

Interventions

Interacting drugs - Cooperstown Cocktail (midazolam, warfarin, (+ vitamin K), caffeine, omeprazole and dextromethorphan)DRUG

Capsules + Tablets + Oral solution, Oral, Midazolam: 5 mg, Warfarin: 10 mg (vitamin K 10 mg), caffeine: 200 mg, omeprazole: 40 mg, dextromethorphan: 30 mg once daily, Day 1, 1 Day

BMS-708163DRUG

Capsules, Oral, 150 mg, once daily, days 6-15, 10 Days

BMS-708163 + Cooperstown CocktailDRUG

Capsules + tablets + Oral solution, Oral, BMS-708163: 150 mg + Midazolam: 5 mg, Warfarin: 10 mg (vitamin K 10 mg), caffeine: 200 mg, omeprazole: 40 mg, dextromethorphan: 30 mg, BMS-708163, once daily, days 16-20 midazolam,warfarin, (+ vitamin K), caffeine, omeprazole and dextromethorphan once daily on Day 16, 5 Days

Eligibility

Sex: MALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy male subjects * 18-45 yrs old inclusive Exclusion Criteria: * Women

Locations (1)

Bristol-Myers Squibb Clinical Pharmacology Unit

Hamilton, New Jersey, United States

Outcomes

Primary Outcomes

Pharmacokinetic effects of BMS-708163 on interacting drugs (midazolam, warfarin, caffeine, omeprazole, and dextromethorphan)

Time frame: throughout the study

Secondary Outcomes

Safety variables (adverse events, vital signs, safety labs)

Time frame: throughout the study

Data from ClinicalTrials.gov

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