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

Information source: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Alzheimer Disease

Intervention: SAM-531 (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Wyeth is now a wholly owned subsidiary of Pfizer

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Wyeth is now a wholly owned subsidiary of Pfizer


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: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: blood samples

Secondary outcome: Safety based on supine vital signs evaluations, 12-lead ECGs and routine lab tests


Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.


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

Gieres 38610, France
Additional Information

Starting date: October 2008
Last updated: February 5, 2010

Page last updated: August 23, 2015

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