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

This study has been completed.

First Received: September 2, 2008 Last Updated: February 5, 2010 History of Changes

Sponsor:	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

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

Resource links provided by NLM:

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease

Drug Information available for: Verapamil

U.S. FDA Resources

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 ]

Enrollment:	14
Study Start Date:	October 2008
Study Completion Date:	December 2008
Primary Completion Date:	December 2008 (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

Locations

France

Gieres, France, 38610

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

No publications provided

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	3193A1-1112
Study First Received:	September 2, 2008
Last Updated:	February 5, 2010
ClinicalTrials.gov Identifier:	NCT00745576 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency; France: Institutional Ethical Committee; United States: Food and Drug Administration

Additional relevant MeSH terms:

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

Neurodegenerative Diseases
Tauopathies
Brain Diseases
Dementia

ClinicalTrials.gov processed this record on February 08, 2010