- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00474552
Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SAM-315
February 13, 2008 updated by: Wyeth is now a wholly owned subsidiary of Pfizer
An Ascending Multiple-Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SAM-315 Administered Orally to Healthy Young Adult and Elderly Subjects
Primary: To assess the safety and tolerability of ascending multiple oral doses of SAM-315, an investigational drug, in healthy young adult and elderly subjects.
Secondary: To assess the Pharmacokinetic and Pharmacodynamic profiles of multiple oral doses of SAM-315 in healthy young adult and elderly subjects.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
56
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
-
-
-
Paris, France, 75015
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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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
Young healthy subjects:
- Men and women of nonchildbearing potential (WONCBP) aged 18 to 45 years inclusive on study day 1.
- Body mass index (BMI) in the range of 18 to 30 kg/m2 and body weight greater than or equal to 50 kg and body weight greater than or equal to 50 kg.
Elderly Healthy subjects:
- Men or women aged 65 years and above as of study day 1.
- BMI in the range of 18 to 30 kg/m2 and body weight greater than or equal to 45 kg and body weight greater than or equal to 45 kg.
Exclusion Criteria:
- Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
- History of any clinically important drug allergy.
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 |
---|---|
Experimental: 1
Experimental-Placebo Comparator
|
Multiple Ascending Doses of SAM-315 (treatment duration: 14 days): 0.2 mg; 0.5 mg; 1 mg; 2 mg;
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
safety, tolerability and PK
Time Frame: 10 months
|
10 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Trial Manager, For France: infomedfrance@wyeth.com
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
June 1, 2007
Primary Completion (Actual)
October 1, 2007
Study Completion (Actual)
October 1, 2007
Study Registration Dates
First Submitted
May 15, 2007
First Submitted That Met QC Criteria
May 15, 2007
First Posted (Estimate)
May 17, 2007
Study Record Updates
Last Update Posted (Estimate)
February 18, 2008
Last Update Submitted That Met QC Criteria
February 13, 2008
Last Verified
February 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3182A1-101
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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