- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00479349
Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of SAM-531
July 6, 2009 updated by: Wyeth is now a wholly owned subsidiary of Pfizer
An Ascending Multiple Dose Study of the Safety, Pharmacokinetics (PK), and Pharmacodynamics (PD) of SAM-531 Administered Orally to Healthy Japanese Young Male and Elderly Subjects
To assess the safety and tolerability of ascending multiple oral doses of SAM-531, an investigational drug, in healthy Japanese young male and elderly subjects.To provide the pharmacokinetics (PK) and pharmacodynamics (PD) profiles of multiple oral doses of SAM-531 in healthy Japanese young male and elderly subjects.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
32
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Tokyo, Japan, 170-0003
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion criteria
- Men aged 20 to 45 years, inclusive, at screening.
- Elderly men or women aged 65 years and above as of screening.
- Body mass index (BMI) in the range of 17.6 to 26.4 kg/m2 and body weight ≥45 kg.
Exclusion critereia
- Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
- Any clinically important deviation from normal limits in physical examination, vital signs, 12-lead ECGs, or clinical laboratory test results. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels should be below the upper limit of normal at screening.
- Tobacco use or consumption of any caffeine-containing products (e.g., coffee, tea, chocolate, or carbonated beverages) or alcoholic beverages within 48 hours before study day 1 until the end of the inpatient confinement period.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: 1
SAM 531 + placebo
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Multiple ascending doses of SAM 531: 1,5; 3 and 5 mg.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Safety and tolerability
Time Frame: 9 months
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9 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pharmacokinetics and pharmacodynamics
Time Frame: 9 months
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9 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2007
Primary Completion (Actual)
January 1, 2008
Study Completion (Actual)
January 1, 2008
Study Registration Dates
First Submitted
May 24, 2007
First Submitted That Met QC Criteria
May 24, 2007
First Posted (Estimate)
May 28, 2007
Study Record Updates
Last Update Posted (Estimate)
July 7, 2009
Last Update Submitted That Met QC Criteria
July 6, 2009
Last Verified
July 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3193A1-1104
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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