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

A Study of the Effect of Concomitant Administration of Multiple Doses of BMS-708163 on the Pharmacokinetics of Galantamine in Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01039194

Enrollment

Registered

2009-12-24

Start date

2010-01-31

Completion date

2010-04-30

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

Interventions

DRUGgalantamine

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

DRUGBMS-708163

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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)	Study Days 14 & 24

Secondary

Measure	Time frame
Galantamine alone and with BMS 708163: Safety and tolerability (AE's, ECG, vital signs, safety labs)	Study Days 7, 14, 18, 25 and study discharge

Countries

United States

Outcome results

None listed

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