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Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SAM-531 in Healthy Japanese Males

Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT00479297
Collaborator
(none)
72
Enrollment
9.1
Duration (Months)

Study Details

Study Description

Brief Summary

To assess the safety and tolerability of ascending single oral doses of SAM-531, an investigational drug, in healthy Japanese male subjects. Secondary: To obtain preliminary pharmacokinetic (PK) and pharmacodynamic (PD) profiles of SAM-531 in healthy Japanese male subjects.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Double
Primary Purpose:
Treatment
Official Title:
Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of SAM-531 Administered Orally to Healthy Japanese Male Subjects
Study Start Date :
May 1, 2006
Actual Primary Completion Date :
Feb 1, 2007
Actual Study Completion Date :
Feb 1, 2007

Outcome Measures

Primary Outcome Measures

  1. Safety and tolerability []

Secondary Outcome Measures

  1. Pharmacokinetics and pharmacodynamics []

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 45 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
Inclusion criteria:

  • Men aged 20 to 45 years (inclusive) at the time of getting informed consent.

  • Body mass index (BMI) in the range of 17.6 to 26.4 kg/m2 and body weight ≥50 kg (BMI = [weight (kg)]/[height (m)2).

  • Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and digital 12-lead electrocardiogram (ECG). Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and creatinine levels must be within the upper limit of normal for eligibility.

Exclusion criteria

  • 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, digital 12-lead ECGs, or clinical laboratory test results.

  • Consumption of any caffeine-containing products (e.g., coffee, tea, chocolate, or soda) or alcoholic beverages is prohibited from 48 hours and consumption of grapefruit or a grapefruit-containing product is prohibited from 72 hours before study day 1.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Wyeth is now a wholly owned subsidiary of Pfizer

Investigators

  • Study Director: Medical Monitor, Wyeth is now a wholly owned subsidiary of Pfizer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00479297
Other Study ID Numbers:
  • 3193A1-101
First Posted:
May 28, 2007
Last Update Posted:
Aug 7, 2009
Last Verified:
Aug 1, 2009
Additional relevant MeSH terms:
Alzheimer Disease

Study Results

No Results Posted as of Aug 7, 2009