NCT00479349

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P50-P75 for phase_1 alzheimer-disease

Timeline
Completed

Started May 2007

Shorter than P25 for phase_1 alzheimer-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

May 24, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 28, 2007

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
Last Updated

July 7, 2009

Status Verified

July 1, 2009

Enrollment Period

8 months

First QC Date

May 24, 2007

Last Update Submit

July 6, 2009

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (1)

  • Safety and tolerability

    9 months

Secondary Outcomes (1)

  • Pharmacokinetics and pharmacodynamics

    9 months

Study Arms (1)

1

ACTIVE COMPARATOR

SAM 531 + placebo

Drug: SAM-531

Interventions

SAM-531DRUG

Multiple ascending doses of SAM 531: 1,5; 3 and 5 mg.

1

Eligibility Criteria

Age20 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Tokyo, 170-0003, Japan

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

SAM-531

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Medical Monitor

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 24, 2007

First Posted

May 28, 2007

Study Start

May 1, 2007

Primary Completion

January 1, 2008

Study Completion

January 1, 2008

Last Updated

July 7, 2009

Record last verified: 2009-07

Locations

JP(1)