NCT00480467

Brief Summary

To assess the safety and tolerability of ascending single oral doses of SAM-315, an investigational drug, in healthy Japanese male subjects.To obtain preliminary pharmacokinetic (PK) and pharmacodynamic (PD) profiles of SAM-315 in healthy Japanese male 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 Sep 2006

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

September 1, 2006

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 29, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 31, 2007

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

December 5, 2007

Status Verified

December 1, 2007

First QC Date

May 29, 2007

Last Update Submit

December 3, 2007

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (1)

  • Safety and tolerability

Secondary Outcomes (1)

  • Pharmacokinetics and pharmacodynamics

Interventions

SAM-315DRUG

Eligibility Criteria

Age20 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Men aged 20 to 45 years (inclusive) at the time of getting informed consent.
  • Body mass index (BMI) in the range of 18.5 to 25.0 kg/m2 and body weight≥50 kg (BMI = \[weight (kg)\]/\[height (m)\]2).
  • Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and digital 12-lead electrocardiogram (ECG). Alanine aminotransferase (ALT), aspartate aminotransferase (AST) and creatinine levels must be within the upper limit of normal for eligibility.

You may not qualify if:

  • 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, digital 12-lead ECGs, or clinical laboratory test results.
  • Consumption of any caffeine-containing products (eg, coffee, tea, chocolate, or cola) or alcoholic beverages is prohibited from 48 hours and consumption of grapefruit or a grapefruit-containing products is prohibited from 72 hours before study day 1.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Ibaraki Pref, 305-0856, Japan

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

3-(naphthalen-1-ylsulfonyl)-5-(piperazin-1-yl)-1H-indazole

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
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 29, 2007

First Posted

May 31, 2007

Study Start

September 1, 2006

Study Completion

August 1, 2007

Last Updated

December 5, 2007

Record last verified: 2007-12

Locations

JP(1)