Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of SAM-531
NCT00479349
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
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1-800-718-1021
- 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.
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Descriptive Information | ||||
---|---|---|---|---|
Brief Title ICMJE | Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of SAM-531 | |||
Official Title ICMJE | 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 | |||
Brief Summary | 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. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment | |||
Condition ICMJE | Alzheimer Disease | |||
Intervention ICMJE | Drug: SAM-531
Multiple ascending doses of SAM 531: 1,5; 3 and 5 mg. | |||
Study Arms ICMJE | Active Comparator: 1
SAM 531 + placebo Intervention: Drug: SAM-531 | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Estimated Enrollment ICMJE | 32 | |||
Original Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | January 2008 | |||
Actual Primary Completion Date | January 2008 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion criteria
Exclusion critereia
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 20 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Japan | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00479349 | |||
Other Study ID Numbers ICMJE | 3193A1-1104 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth | |||
Study Sponsor ICMJE | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Verification Date | July 2009 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |