Drug-Drug Interaction to Study the Effect of BMS-708163 on Pharmacokinetics (PK) of Galantamine Extended Release (ER)

Bristol-Myers Squibb18 enrolled

Overview

The purpose of the study is to find out if the plasma concentration of galantamine extended release is changed when BMS-708163 is administered at the same time.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Masking

NONE

Enrollment

Conditions

Alzheimer Disease

Interventions

galantamineDRUG

Capsule, Oral, 8 mg (ER), once daily, Days 1-7

galantamineDRUG

Capsule, Oral, 16 mg (ER), once daily, Days 8-24

BMS-708163DRUG

Capsule, Oral, 125 mg, once daily, Days 15-24

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy men and postmenopausal women Exclusion Criteria: * Gastrointestinal disorders * Bleeding disorders * Peptic ulcer disease * Cholecystectomy * Seizure disorder * Asthma * Chronic obstructive pulmonary disease * Urinary tract obstruction * Cardiac conduction abnormalities, including but not limited to "sick sinus syndrome" and those with unexplained syncopal episodes * Inability to tolerate oral medication * Inability to be venipunctured and/or tolerate venous access

Locations (1)

Parexel International - Baltimore Epcu

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

Galantamine alone and with BMS-708163: Galantamine PK parameters (Cmax, Tmax, AUC(TAU) and Ctrough rations will be assessed without BMS-708163 Day 14) and with BMS708-163 (Ctrough Day 24)

Time frame: Study Days 14 & 24

Secondary Outcomes

Galantamine alone and with BMS 708163: Safety and tolerability (AE's, ECG, vital signs, safety labs)

Time frame: Study Days 7, 14, 18, 25 and study discharge

Data from ClinicalTrials.gov

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