Study Evaluating Safety, Tolerability and Pharmacokinetics of Single and Multiple Dose of SAM-531
Primary Purpose
Alzheimer Disease
Status
Completed
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
SAM-531
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer Disease
Eligibility Criteria
Inclusion criteria:
- Body mass index in the range of 18 to 30 kg/m2 and body weight greater than or equal to 50 kg. Body weight for elderly subjects must be greater than or equal to 45 kg.
- history, physical examination findings, clinical laboratory test results, vital sign measurements, and digital 12-lead ECG readings.
Exclusion criteria:
- Presence or history of any disorder that may prevent the successful completion of the study.
- Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal (GI), endocrine, immunologic, dermatologic, hematologic, neurologic or psychiatric disease.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
1
2
Arm Description
arm placebo
arm drug
Outcomes
Primary Outcome Measures
Pharmacokinetics, routine Lab tests, Vital signs, ECG
Secondary Outcome Measures
Full Information
NCT ID
NCT00726115
First Posted
July 28, 2008
Last Updated
July 29, 2009
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00726115
Brief Title
Study Evaluating Safety, Tolerability and Pharmacokinetics of Single and Multiple Dose of SAM-531
Official Title
Safety, Tolerability, and Pharmacokinetics, of Single and Multiple Dose of SAM-531 Administered Orally To Healthy Young and Elderly Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
February 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The main objectives of this study is to assess the safety and tolerability of ascending single and multiple oral doses of SAM-531 in healthy 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
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Placebo Comparator
Arm Description
arm placebo
Arm Title
2
Arm Type
Experimental
Arm Description
arm drug
Intervention Type
Drug
Intervention Name(s)
SAM-531
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
Pharmacokinetics, routine Lab tests, Vital signs, ECG
Time Frame
29 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria:
Body mass index in the range of 18 to 30 kg/m2 and body weight greater than or equal to 50 kg. Body weight for elderly subjects must be greater than or equal to 45 kg.
history, physical examination findings, clinical laboratory test results, vital sign measurements, and digital 12-lead ECG readings.
Exclusion criteria:
Presence or history of any disorder that may prevent the successful completion of the study.
Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal (GI), endocrine, immunologic, dermatologic, hematologic, neurologic or psychiatric disease.
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
Facility Information:
City
Rueil Malmaison
ZIP/Postal Code
92502
Country
France
12. IPD Sharing Statement
Learn more about this trial
Study Evaluating Safety, Tolerability and Pharmacokinetics of Single and Multiple Dose of SAM-531
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