NCT00684710

Brief Summary

This study will provide an initial assessment of the safety, tolerability, and pharmacokinetics (PK) of PAZ-417 after administration of ascending single oral doses to healthy young Japanese male and healthy elderly Japanese male subjects.

Trial Health

87
On Track

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 Apr 2008

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

April 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 23, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 28, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

January 30, 2009

Status Verified

January 1, 2009

Enrollment Period

4 months

First QC Date

May 23, 2008

Last Update Submit

January 28, 2009

Conditions

Alzheimer DiseaseHealthy

Keywords

Alzheimer Disease

Outcome Measures

Primary Outcomes (1)

  • Safety and Tolerability

    3 months

Secondary Outcomes (1)

  • Pharmacokinetics

    3 months

Study Arms (2)

PAZ-417

EXPERIMENTAL
Drug: PAZ-417

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

PAZ-417DRUG
PAZ-417
PlaceboDRUG
Placebo

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 (healthy young male subjects) and ≥65 years inclusive (healthy elderly male subjects)
  • Nonsmoker or smoker of fewer than 10 cigarettes per day.
  • Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead electrocardiogram (ECG).

You may not qualify if:

  • Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
  • Subjects who are identified as being at risk for hypercoagulability
  • Use of any investigational or prescription drug within 30 days before test article administration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Kitashinagawa, Shinagawa-ku, Tokyo, 141-0001, Japan

Location

MeSH Terms

Conditions

Alzheimer Disease

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
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 23, 2008

First Posted

May 28, 2008

Study Start

April 1, 2008

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

January 30, 2009

Record last verified: 2009-01

Locations

JP(1)