Study Evaluating The Potential Interaction Between Verapamil Immediate Release And SAM-531 When Co-Administered - Full Text View

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00745576

Purpose

The purpose of this study is to evaluate the effects of multiple doses of verapamil on the plasma concentration of a single dose of SAM-531 in healthy young adult subjects and to assess the safety and tolerability of co-administration of SAM-531 and verapamil.

Condition	Intervention	Phase
Alzheimer Disease	Drug: SAM-531	Phase I

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease

Drug Information available for: Diltiazem Verapamil Dexverapamil Diltiazem hydrochloride Diltiazem malate Verapamil hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Pharmacokinetics Study
Official Title:	An Open-Label, Nonrandomized Study to Evaluate the Potential Pharmacokinetic Interaction Between Multiple Doses of Verapamil Immediate Release (IR) and a Single Dose of SAM-531 When Co-Administered Orally to Healthy Young Adult Subjects

Further study details as provided by Wyeth:

Primary Outcome Measures:

blood samples [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety based on supine vital signs evaluations, 12-lead ECGs and routine lab tests [ Time Frame: 7 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	15
Study Start Date:	October 2008
Estimated Study Completion Date:	February 2009
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: SAM-531

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion criteria :

Body mass index in the range of 18 to 30 kg/m2 and body weight greater than 50 kg.
Healthy as determined by the investigator on the basis of medical history, physical examination findings, clinical laboratory test results, vital sign measurements, and digital 12-lead ECG readings.

Exclusion criteria :

Presence or history of any disorder that may prevent the successful completion of the study.
Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal (GI), endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00745576

Contacts

Contact: Trial Manager

clintrialparticipation@wyeth.com

Locations

France
	Recruiting
Gieres, France, 38610

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	3193A1-1112
Study First Received:	September 2, 2008
Last Updated:	October 24, 2008
ClinicalTrials.gov Identifier:	NCT00745576
Health Authority:	France: Afssaps - French Health Products Safety Agency; France: Institutional Ethical Committee; United States: Food and Drug Administration

Study placed in the following topic categories:

Verapamil
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Diltiazem
Alzheimer Disease
Central Nervous System Diseases

Healthy
Neurodegenerative Diseases
Brain Diseases
Dementia
Cognition Disorders
Delirium

Additional relevant MeSH terms:

Nervous System Diseases
Tauopathies

ClinicalTrials.gov processed this record on January 16, 2009