You are here

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

Last updated on May 11, 2018

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

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your zip code, city, or country to find studies near you.

Similar Trials

Non-alcoholic Steatohepatitis, Non-alcoholic Fatty Liver Disease
NCT03513588
All Genders
Nonalcoholic Fatty Liver Disease, Nonalcoholic Steatohepatitis
NCT03248882
All Genders
18+
Years
Multiple Sites
Hypercholesterolemia Coronary Artery Disease
NCT02565615
All Genders
18+
Years
Multiple Sites
Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of SAM-531 in Healthy Young and Elderly Subjects
An Ascending Multiple Dose Study of the Safety, Pharmacokinetics (PK), and Pharmacodynamics (PD) of SAM-531 Administered Orally to Healthy Young and Elderly Subjects
To 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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Alzheimer Disease
Drug: SAM-531
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
July 2007
Not Provided

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT00480818
3193A1-102
Not Provided
Not Provided
Not Provided
Not Provided
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
December 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 thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



Call Now