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

Primary Purpose

Alzheimer Disease

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
SAM-531
Sponsored by
Wyeth is now a wholly owned subsidiary of Pfizer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer Disease

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion criteria

  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

  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.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Safety and tolerability

    Secondary Outcome Measures

    Pharmacokinetics and pharmacodynamics

    Full Information

    First Posted
    May 24, 2007
    Last Updated
    December 7, 2007
    Sponsor
    Wyeth is now a wholly owned subsidiary of Pfizer
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00479700
    Brief Title
    Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SAM-531 in Healthy Subjects
    Official Title
    Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of SAM-531 Administered Orally to Healthy Subjects
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2007
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2006 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    July 2006 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Wyeth is now a wholly owned subsidiary of Pfizer

    4. Oversight

    5. Study Description

    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.

    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
    Single Group Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    80 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    SAM-531
    Primary Outcome Measure Information:
    Title
    Safety and tolerability
    Secondary Outcome Measure Information:
    Title
    Pharmacokinetics and pharmacodynamics

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion criteria Men or women of nonchildbearing potential aged 18 to 45 years Elderly men or women aged 65 years and above as of study day 1. 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 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. 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.
    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

    12. IPD Sharing Statement

    Learn more about this trial

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

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