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

Last updated on November 14, 2019

FOR MORE INFORMATION
Study Location
Rennes, , 35000 France
Contact
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
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

- 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.

NCT00480818
Pfizer
Completed
Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of SAM-531 in Healthy Young and Elderly Subjects

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Descriptive Information
Brief Title  ICMJE Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of SAM-531 in Healthy Young and Elderly Subjects
Official Title  ICMJE An Ascending Multiple Dose Study of the Safety, Pharmacokinetics (PK), and Pharmacodynamics (PD) of SAM-531 Administered Orally to Healthy Young and Elderly Subjects
Brief SummaryTo assess the safety and tolerability of ascending multiple oral doses of SAM-531, an investigational drug, in healthy young adult and elderly subjects.To assess the pharmacokinetics (PK) and pharmacodynamics (PD) profiles of multiple oral doses of SAM-531 in healthy young adult and elderly subjects.
Detailed DescriptionNot 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
 (submitted: May 29, 2007)
80
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2007
Primary Completion DateNot Provided
Eligibility Criteria  ICMJE

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.
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 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 France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00480818
Other Study ID Numbers  ICMJE 3193A1-102
Has Data Monitoring CommitteeNot Provided
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyNot Provided
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
PRS AccountWyeth is now a wholly owned subsidiary of Pfizer
Verification DateDecember 2007

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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

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Contact

[email protected]

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