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CompletedNCT00366288Updated Jul 10, 2009

Study Evaluating PAZ-417 in Healthy Young/Elderly

An observational study in Alzheimer Disease, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-07-10.

Sponsored by Wyeth is now a wholly owned subsidiary of Pfizer (part of Pfizer) · Observational

Study type
Observational
Model
Cohort
Enrollment
56
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Alzheimer Disease

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Keywords

  • Healthy
  • Safety
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In context

Alzheimer Disease

3,765 studies on the registry are indexed under Alzheimer Disease; 881 are open to participants now.

This study's planned enrollment of 56 is below the median of 200 across 780 observational studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer is the lead sponsor of 484 studies on the registry; none are open to participants now.

First submitted before Wyeth became part of Pfizer.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Residents of a certain town

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. 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.
  2. 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.
  3. The estimated creatinine clearance must be within the age-appropriate normal range.

Exclusion criteria

Exclusions Criteria:

  1. Presence or history of any disorder that may prevent the successful completion of the study.
  2. Any surgical or medical condition that may interfere with the absorption, distribution, metabolism, or excretion of the test article.
  3. 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).
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Study design

Observational model
Cohort
Enrollment
56 participants (estimated)
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

  • 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.

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Study locations

1 site
  • Phoenix, Arizona 85044, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 10, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00366288
First posted
Aug 21, 2006
Start date
Jul 2006
Primary completion
Mar 2008
Completion
Mar 2008
Last update
Jul 10, 2009

Study contacts

Medical Monitor
study director · Wyeth is now a wholly owned subsidiary of Pfizer
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2009. You cannot join it, but the record below documents what was studied.

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Discussion

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