Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SAM-531 in Healthy Subjects
NCT00479700
Last updated date
ABOUT THIS STUDY
To assess the safety and tolerability of ascending single oral doses of SAM-531 in healthy
subjects.To obtain preliminary pharmacokinetic (PK) and pharmacodynamic (PD) profiles of
SAM-531, an investigational drug, in healthy subjects and to evaluate the effect of a
high-fat meal on the PK of SAM-531 administered to healthy subjects.
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Alzheimer Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
18-45 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
1. Men or women of nonchildbearing potential aged 18 to 45 years
2. Elderly men or women aged 65 years and above as of study day 1.
3. Body mass index in the range of 18 to 30 kg/m2 and body weight ≥50 kg. Body weight for elderly subjects must be ≥45 kg.
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
1. Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal,
endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease
2. Any clinically important deviation from normal limits in physical examination, vital
signs, digital 12-lead ECGs, or clinical laboratory test results.
3. Tobacco use or the consumption of any caffeine-containing products (e.g., coffee, tea,
chocolate, or soda) or alcoholic beverages within 48 hours before study day 1, or
grapefruit or grapefruit-containing products 72 hours before study day 1, and until
the end of the inpatient confinement period.
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Advanced Information
| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SAM-531 in Healthy Subjects | |||
| Official Title ICMJE | Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of SAM-531 Administered Orally to Healthy Subjects | |||
| Brief Summary | To assess the safety and tolerability of ascending single oral doses of SAM-531 in healthy subjects.To obtain preliminary pharmacokinetic (PK) and pharmacodynamic (PD) profiles of SAM-531, an investigational drug, in healthy subjects and to evaluate the effect of a high-fat meal on the PK of SAM-531 administered to healthy 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 Primary Purpose: Treatment | |||
| Condition ICMJE | Alzheimer Disease | |||
| Intervention ICMJE | Drug: SAM-531 | |||
| Study Arms ICMJE | Not Provided | |||
| 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 | |||
| Enrollment ICMJE | 80 | |||
| Original Enrollment ICMJE | Same as current | |||
| Actual Study Completion Date ICMJE | July 2006 | |||
| Primary Completion Date | Not Provided | |||
| Eligibility Criteria ICMJE | Inclusion criteria
Exclusion criteria
| |||
| Sex/Gender ICMJE |
| |||
| Ages ICMJE | 18 Years to 45 Years (Adult) | |||
| Accepts Healthy Volunteers ICMJE | Yes | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | Not Provided | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00479700 | |||
| Other Study ID Numbers ICMJE | 3193A1-100 | |||
| Has Data Monitoring Committee | Not Provided | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Not Provided | |||
| 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 | December 2007 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||