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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00745576 |
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Date of registration:
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02/09/2008 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Study Evaluating The Potential Interaction Between Verapamil Immediate Release And SAM-531 When Co-Administered
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Scientific title:
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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 |
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Date of first enrolment:
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October 2008 |
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Target sample size:
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14 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00745576 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 1
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Countries of recruitment
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France
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Contacts
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Name:
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Medical Monitor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Wyeth is now a wholly owned subsidiary of Pfizer |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
55 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Alzheimer Disease
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Intervention(s)
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Drug: SAM-531
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Primary Outcome(s)
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blood samples
[Time Frame: 7 weeks]
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Secondary Outcome(s)
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Safety based on supine vital signs evaluations, 12-lead ECGs and routine lab tests
[Time Frame: 7 weeks]
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Secondary ID(s)
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3193A1-1112
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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