Study Evaluating The Potential Interaction Between Verapamil Immediate Release And SAM-531 When Co-Administered
Information source: Wyeth
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Alzheimer Disease
Intervention: SAM-531 (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: Wyeth Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Wyeth
Overall contact:
Trial Manager, Email: clintrialparticipation@wyeth.com
Summary
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.
Clinical Details
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
Study design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Pharmacokinetics Study
Primary outcome: blood samples
Secondary outcome: Safety based on supine vital signs evaluations, 12-lead ECGs and routine lab tests
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
Inclusion criteria :
1. Body mass index in the range of 18 to 30 kg/m2 and body weight greater than 50 kg.
2. 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 :
1. Presence or history of any disorder that may prevent the successful completion of the
study.
2. Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal (GI),
endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric
disease.
Locations and Contacts
Trial Manager, Email: clintrialparticipation@wyeth.com
Gieres 38610, France; Recruiting
Additional Information
Starting date: October 2008
Ending date: February 2009
Last updated: October 24, 2008
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