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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Alzheimer Disease

Treatments: Drug: galantamine; Drug: BMS-708163

Study type: Interventional

Funder types: Industry

Identifiers

NCT01039194

CN156-009

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No 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

Trial design

18 participants in 3 patient groups

galantamine 8 mg (ER)

Active Comparator group

Treatment:

Drug: galantamine

Drug: galantamine

galantamine 16 mg (ER)

Active Comparator group

Treatment:

Drug: galantamine

Drug: galantamine

BMS-708163

Active Comparator group

Treatment:

Drug: BMS-708163