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Sponsored by: |
Wyeth |
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Information provided by: | Wyeth |
ClinicalTrials.gov Identifier: | NCT00474552 |
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.
Condition | Intervention | Phase |
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Alzheimer Disease |
Drug: SAM-315 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Single Group Assignment, Safety Study |
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 |
Estimated Enrollment: | 56 |
Study Start Date: | June 2007 |
Study Completion Date: | October 2007 |
Primary Completion Date: | October 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Experimental-Placebo Comparator
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Drug: SAM-315
Multiple Ascending Doses of SAM-315 (treatment duration: 14 days): 0.2 mg; 0.5 mg; 1 mg; 2 mg;
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Young healthy subjects:
Elderly Healthy subjects:
Exclusion Criteria:
Responsible Party: | Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) ) |
Study ID Numbers: | 3182A1-101 |
Study First Received: | May 15, 2007 |
Last Updated: | February 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00474552 History of Changes |
Health Authority: | France: Afssaps - French Health Products Safety Agency; France: Institutional Ethical Committee; United States: Food and Drug Administration |
Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Alzheimer Disease Central Nervous System Diseases Healthy |
Neurodegenerative Diseases Brain Diseases Dementia Cognition Disorders Delirium |
Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Nervous System Diseases Alzheimer Disease Central Nervous System Diseases |
Neurodegenerative Diseases Tauopathies Brain Diseases Dementia |