Study Evaluating PAZ-417 in Healthy Young/Elderly

NCT00366288 | Completed

• 1 other identifier: 3186A1-100
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to evaluate the safety and tolerability of single, ascending doses of PAZ-417 in healthy young and healthy elderly subjects. The effect of a high fat meal on the metabolism of PAZ-417 will also be studied, along with blood levels of PAZ-417 . Changes in cognitive function will be assessed.

Conditions

Alzheimer Disease

Keywords

Healthy; Safety

Study Arms (7)

1

Drug: PAZ-417

2

Drug: PAZ-417

3

Drug: PAZ-417

4

Drug: PAZ-417

5

Drug: PAZ-417

6

Drug: PAZ-417

7

Drug: PAZ-417

Interventions

PAZ-417 DRUG

2.5 mg, 5, 10, 25, 50 mg - fasted in healthy young 10 mg - food effect in healthy young 5 and 25 mg -fasted healthy elderly.

1; 2; 3; 4; 5; 6; 7

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Residents of a certain town

You may qualify if:

• Men or women, aged 18 to 50 years inclusive (healthy young subjects) and \> 65 years inclusive (elderly subjects) on study day 1. Women of nonchildbearing potential may be included if they are either surgically sterile (hysterectomy and/or oophorectomy) or postmenopausal for ≥1 year (with estradiol ≤25 pg/mL\[92 pmol/L\] and FSH ≥40 mIU/mL) and must have a negative serum pregnancy test result within 48 hours before administration of test article. Women who are surgically sterile or post-menopausal must provide documentation of the procedure by an operative report or by ultrasound and have a negative serum pregnancy test result within 48 hours before administration of test article.
• The elderly subjects must be generally healthy, but may be enrolled with a stable, chronic illness, if it is well-controlled, and does not interfere with the primary objective of the study. Subjects may be included with clinically important deviations from normal limits in medical history, physical examination, vital signs, 12-lead ECGs, or clinical laboratory test results which are associated with stable, chronic, well-controlled, medical conditions.
• The estimated creatinine clearance must be within the age-appropriate normal range.
• Presence or history of any disorder that may prevent the successful completion of the study.
• Any surgical or medical condition that may interfere with the absorption, distribution, metabolism, or excretion of the test article.
• Exclude subjects with a history of vascular disorders (peripheral, coronary, venous), chronic inflammatory disorders (e.g., rheumatoid arthritis), hematologic disorders, and bleeding disorders (e.g., hemophilia, idiopathic thrombocytopenic purpura, von willebrand's disease).

Sponsors & Collaborators

• Wyeth is now a wholly owned subsidiary of Pfizer: lead

Study Sites (1)

Unknown Facility

Phoenix, Arizona, 85044, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

plasma and urine

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Medical Monitor

  Wyeth is now a wholly owned subsidiary of Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 17, 2006
• First Posted: August 21, 2006
• Study Start: July 1, 2006
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: July 10, 2009

Record last verified: 2009-07

Locations

US (1)