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

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01039194
First received: December 22, 2009
Last updated: January 24, 2011
Last verified: February 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Alzheimer Disease
 Drug: galantamine
Drug: BMS-708163
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: A Study of the Effect of Concomitant Administration of Multiple Doses of BMS-708163 on the Pharmacokinetics of Galantamine in Healthy Subjects

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 18
Study Start Date: January 2010
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: galantamine 8 mg (ER) Drug: galantamine
Capsule, Oral, 8 mg (ER), once daily, Days 1-7
Other Name: Razadyne ER ™
Active Comparator: galantamine 16 mg (ER) Drug: galantamine
Capsule, Oral, 16 mg (ER), once daily, Days 8-24
Other Name: Razadyne ER ™
Active Comparator: BMS-708163 Drug: BMS-708163
Capsule, Oral, 125 mg, once daily, Days 15-24

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01039194

Locations
United States, Maryland
Parexel International - Baltimore Epcu
Baltimore, Maryland, United States, 21225
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
BMS Clinical Trials Disclosure  This link exits the ClinicalTrials.gov site
Investigator Inquiry form  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01039194     History of Changes
Other Study ID Numbers: CN156-009
Study First Received: December 22, 2009
Last Updated: January 24, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Galantamine
Parasympathomimetics
Autonomic Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nootropic Agents
Central Nervous System Agents
Therapeutic Uses
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on May 23, 2013