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Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SAM-315

Last updated on December 15, 2017

FOR MORE INFORMATION
Study Location
Paris, , 75015 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

Young healthy subjects:

- Men and women of nonchildbearing potential (WONCBP) aged 18 to 45 years inclusive on
study day 1.

- Body mass index (BMI) in the range of 18 to 30 kg/m2 and body weight greater than or
equal to 50 kg and body weight greater than or equal to 50 kg.

Elderly Healthy subjects:

- Men or women aged 65 years and above as of study day 1.

- BMI in the range of 18 to 30 kg/m2 and body weight greater than or equal to 45 kg and
body weight greater than or equal to 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.

- History of any clinically important drug allergy.

NCT00474552
Pfizer
Terminated
Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SAM-315

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Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SAM-315
An Ascending Multiple-Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SAM-315 Administered Orally to Healthy Young Adult and Elderly Subjects

Primary: To assess the safety and tolerability of ascending multiple oral doses of SAM-315, an investigational drug, in healthy young adult and elderly subjects.

Secondary: To assess the Pharmacokinetic and Pharmacodynamic profiles of multiple oral doses of SAM-315 in healthy young adult and elderly subjects.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Alzheimer Disease
Drug: SAM-315
Multiple Ascending Doses of SAM-315 (treatment duration: 14 days): 0.2 mg; 0.5 mg; 1 mg; 2 mg;
Experimental: 1
Experimental-Placebo Comparator
Intervention: Drug: SAM-315
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
56
October 2007
October 2007   (Final data collection date for primary outcome measure)

Inclusion Criteria:

Young healthy subjects:

  • Men and women of nonchildbearing potential (WONCBP) aged 18 to 45 years inclusive on study day 1.
  • Body mass index (BMI) in the range of 18 to 30 kg/m2 and body weight greater than or equal to 50 kg and body weight greater than or equal to 50 kg.

Elderly Healthy subjects:

  • Men or women aged 65 years and above as of study day 1.
  • BMI in the range of 18 to 30 kg/m2 and body weight greater than or equal to 45 kg and body weight greater than or equal to 45 kg.

Exclusion Criteria:

  • Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
  • History of any clinically important drug allergy.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT00474552
3182A1-101
Not Provided
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
Principal Investigator: Trial Manager For France: [email protected]
Wyeth is now a wholly owned subsidiary of Pfizer
February 2008

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.

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

[email protected]



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