Drug-Drug Interaction to Study the Effect of BMS-708163 on Pharmacokinetics (PK) of Galantamine Extended Release (ER)
- Registration Number
- NCT01039194
- Lead Sponsor
- Bristol-Myers Squibb
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description BMS-708163 BMS-708163 - galantamine 8 mg (ER) galantamine - galantamine 16 mg (ER) galantamine -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Parexel International - Baltimore Epcu
🇺🇸Baltimore, Maryland, United States