NCT00474552

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
56

participants targeted

Target at P75+ for phase_1 alzheimer-disease

Timeline
Completed

Started Jun 2007

Shorter than P25 for phase_1 alzheimer-disease

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

May 15, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 17, 2007

Completed
15 days until next milestone

Study Start

First participant enrolled

June 1, 2007

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

February 18, 2008

Status Verified

February 1, 2008

Enrollment Period

4 months

First QC Date

May 15, 2007

Last Update Submit

February 13, 2008

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (1)

  • safety, tolerability and PK

    10 months

Study Arms (1)

1

EXPERIMENTAL

Experimental-Placebo Comparator

Drug: SAM-315

Interventions

SAM-315DRUG

Multiple Ascending Doses of SAM-315 (treatment duration: 14 days): 0.2 mg; 0.5 mg; 1 mg; 2 mg;

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
  • History of any clinically important drug allergy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Paris, 75015, France

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

  • Trial Manager

    For France: infomedfrance@wyeth.com

    PRINCIPAL INVESTIGATOR

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 15, 2007

First Posted

May 17, 2007

Study Start

June 1, 2007

Primary Completion

October 1, 2007

Study Completion

October 1, 2007

Last Updated

February 18, 2008

Record last verified: 2008-02

Locations

FR(1)