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
1 other identifier
interventional
18
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 alzheimer-disease
Started Jan 2010
Shorter than P25 for phase_1 alzheimer-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 22, 2009
CompletedFirst Posted
Study publicly available on registry
December 24, 2009
CompletedStudy Start
First participant enrolled
January 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedJanuary 25, 2011
February 1, 2010
3 months
December 22, 2009
January 24, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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
Study Arms (3)
galantamine 8 mg (ER)
ACTIVE COMPARATORgalantamine 16 mg (ER)
ACTIVE COMPARATORBMS-708163
ACTIVE COMPARATORInterventions
Capsule, Oral, 8 mg (ER), once daily, Days 1-7
Eligibility Criteria
You may qualify if:
- Healthy men and postmenopausal women
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Parexel International - Baltimore Epcu
Baltimore, Maryland, 21225, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 22, 2009
First Posted
December 24, 2009
Study Start
January 1, 2010
Primary Completion
April 1, 2010
Study Completion
April 1, 2010
Last Updated
January 25, 2011
Record last verified: 2010-02