Text Size

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

This study has been terminated.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00474552
First received: May 15, 2007
Last updated: February 13, 2008
Last verified: February 2008
History of Changes

May 15, 2007
February 13, 2008
June 2007
October 2007   (final data collection date for primary outcome measure)
safety, tolerability and PK [ Time Frame: 10 months ] [ Designated as safety issue: Yes ]
safety, tolerability and PK
Complete list of historical versions of study NCT00474552 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, 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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00474552
3182A1-101
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: infomedfrance@wyeth.com
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