Back to resultsStudy Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SAM-315
Primary Purpose
Alzheimer Disease
Status
Terminated
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
SAM-315
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer Disease
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Experimental-Placebo Comparator
Outcomes
Primary Outcome Measures
safety, tolerability and PK
Secondary Outcome Measures
Full Information
NCT ID
NCT00474552
First Posted
May 15, 2007
Last Updated
February 13, 2008
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00474552
Brief Title
Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SAM-315
Official Title
An Ascending Multiple-Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SAM-315 Administered Orally to Healthy Young Adult and Elderly Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
February 2008
Overall Recruitment Status
Terminated
Study Start Date
June 2007 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
October 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
56 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Experimental-Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
SAM-315
Intervention Description
Multiple Ascending Doses of SAM-315 (treatment duration: 14 days): 0.2 mg; 0.5 mg; 1 mg; 2 mg;
Primary Outcome Measure Information:
Title
safety, tolerability and PK
Time Frame
10 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Wyeth is now a wholly owned subsidiary of Pfizer
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Trial Manager
Organizational Affiliation
For France: infomedfrance@wyeth.com
Official's Role
Principal Investigator
Facility Information:
City
Paris
ZIP/Postal Code
75015
Country
France
12. IPD Sharing Statement
Learn more about this trial
Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SAM-315
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