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Study Evaluating Safety, Tolerability and Pharmacokinetics of Single and Multiple Dose of SAM-531

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Rueil Malmaison, , 92502 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
18-65 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Body mass index in the range of 18 to 30 kg/m2 and body weight greater than or equal
to 50 kg. Body weight for elderly subjects must be greater than or equal to 45 kg.

- history, physical examination findings, clinical laboratory test results, vital sign
measurements, and digital 12-lead ECG readings.

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

- Presence or history of any disorder that may prevent the successful completion of the
study.

- Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal (GI),
endocrine, immunologic, dermatologic, hematologic, neurologic or psychiatric disease.

NCT00726115
Pfizer
Completed
Study Evaluating Safety, Tolerability and Pharmacokinetics of Single and Multiple Dose of SAM-531

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[email protected]

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Study Evaluating Safety, Tolerability and Pharmacokinetics of Single and Multiple Dose of SAM-531
Safety, Tolerability, and Pharmacokinetics, of Single and Multiple Dose of SAM-531 Administered Orally To Healthy Young and Elderly Subjects
The main objectives of this study is to assess the safety and tolerability of ascending single and multiple oral doses of SAM-531 in healthy subjects
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Alzheimer Disease
  • Drug: SAM-531
  • Drug: placebo
  • Placebo Comparator: 1
    arm placebo
    Intervention: Drug: SAM-531
  • Experimental: 2
    arm drug
    Intervention: Drug: placebo
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
56
February 2009
February 2009   (Final data collection date for primary outcome measure)

Inclusion criteria:

  • Body mass index in the range of 18 to 30 kg/m2 and body weight greater than or equal to 50 kg. Body weight for elderly subjects must be greater than or equal to 45 kg.
  • history, physical examination findings, clinical laboratory test results, vital sign measurements, and digital 12-lead ECG readings.

Exclusion criteria:

  • Presence or history of any disorder that may prevent the successful completion of the study.
  • Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal (GI), endocrine, immunologic, dermatologic, hematologic, neurologic or psychiatric disease.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT00726115
3193A1-1111
No
Not Provided
Not Provided
Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
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
July 2009

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]



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