You are here

Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of SAM-531

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Tokyo, , 170-0003 Japan
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Alzheimer Disease
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
20+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Men aged 20 to 45 years, inclusive, at screening.

- Elderly men or women aged 65 years and above as of screening.

- Body mass index (BMI) in the range of 17.6 to 26.4 kg/m2 and body weight ≥45 kg.

Exclusion critereia

- 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, 12-lead ECGs, or clinical laboratory test results. Alanine aminotransferase
(ALT) and aspartate aminotransferase (AST) levels should be below the upper limit of
normal at screening.

- Tobacco use or consumption of any caffeine-containing products (e.g., coffee, tea,
chocolate, or carbonated beverages) or alcoholic beverages within 48 hours before
study day 1 until the end of the inpatient confinement period.

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

- Men aged 20 to 45 years, inclusive, at screening.

- Elderly men or women aged 65 years and above as of screening.

- Body mass index (BMI) in the range of 17.6 to 26.4 kg/m2 and body weight ≥45 kg.

Exclusion critereia

- 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, 12-lead ECGs, or clinical laboratory test results. Alanine aminotransferase
(ALT) and aspartate aminotransferase (AST) levels should be below the upper limit of
normal at screening.

- Tobacco use or consumption of any caffeine-containing products (e.g., coffee, tea,
chocolate, or carbonated beverages) or alcoholic beverages within 48 hours before
study day 1 until the end of the inpatient confinement period.

NCT00479349
Pfizer
Completed
Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of SAM-531

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

Chronic Disease, Pain
NCT01179191
All Genders
21+
Years
Multiple Sites
Gastroesophageal Reflux Disease
NCT02401035
All Genders
1+
Years
Multiple Sites
Nonalcoholic Fatty Liver Disease, Nonalcoholic Steatohepatitis
NCT03248882
All Genders
18+
Years
Multiple Sites
Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of SAM-531
An Ascending Multiple Dose Study of the Safety, Pharmacokinetics (PK), and Pharmacodynamics (PD) of SAM-531 Administered Orally to Healthy Japanese Young Male and Elderly Subjects
To assess the safety and tolerability of ascending multiple oral doses of SAM-531, an investigational drug, in healthy Japanese young male and elderly subjects.To provide the pharmacokinetics (PK) and pharmacodynamics (PD) profiles of multiple oral doses of SAM-531 in healthy Japanese young male 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-531
Multiple ascending doses of SAM 531: 1,5; 3 and 5 mg.
Active Comparator: 1
SAM 531 + placebo
Intervention: Drug: SAM-531
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
January 2008
January 2008   (Final data collection date for primary outcome measure)

Inclusion criteria

  • Men aged 20 to 45 years, inclusive, at screening.
  • Elderly men or women aged 65 years and above as of screening.
  • Body mass index (BMI) in the range of 17.6 to 26.4 kg/m2 and body weight ?45 kg.

Exclusion critereia

  • 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, 12-lead ECGs, or clinical laboratory test results. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels should be below the upper limit of normal at screening.
  • Tobacco use or consumption of any caffeine-containing products (e.g., coffee, tea, chocolate, or carbonated beverages) or alcoholic beverages within 48 hours before study day 1 until the end of the inpatient confinement period.
Sexes Eligible for Study: Male
20 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT00479349
3193A1-1104
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
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]



Call Now