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...
Date First Received: September 2, 2008
Last Updated: October 24, 2008
Verified by: Wyeth, October 2008
Clinical Trial Phase: Phase 1 | Start Date: October 2008
Overall Status: Recruiting
Estimated Enrollment: 15
Brief Summary
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”
Condition Keyword(s):
Intervention(s):
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.
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Pharmacokinetics Study
Study Primary Completion Date: February 2009
Intervention(s) in this Clinical Trial
- Drug: SAM-531
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: 1
Outcome Measures for this Clinical Trial
Primary Measures
- blood samples
- Time Frame: 7 weeks
Safety Issue?: No
- Time Frame: 7 weeks
Secondary Measures
- Safety based on supine vital signs evaluations, 12-lead ECGs and routine lab tests
- Time Frame: 7 weeks
Safety Issue?: Yes
- Time Frame: 7 weeks
Criteria for Participation in this Clinical Trial
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.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 55 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers
Clinical Trial Sponsor Information
Lead Sponsor: Wyeth
Overall Clinical Trial Officials and Contacts
Medical Monitor Study Director Wyeth
Overall Contact: Trial Manager clintrialparticipation@wyeth.com
Additional Information
Information obtained from ClinicalTrials.gov on July 02, 2009
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00745576
Study ID Number: 3193A1-1112
ClinicalTrials.gov Identifier: NCT00745576
Health Authority: France: Afssaps - French Health Products Safety Agency
Clinical Trials Authorship and Review
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