Study Evaluating PAZ-417 in Healthy Young/Elderly

• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
• Information provided by: Wyeth is now a wholly owned subsidiary of Pfizer

Study Description

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.

Condition or disease	Intervention/treatment
Alzheimer Disease	Drug: PAZ-417

Study Design

• Study Type: Observational
• Estimated Enrollment: 56 participants
• Observational Model: Cohort
• Official Title: Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PAZ-417 Administered Orally to Healthy Young and Healthy Elderly Subjects
• Study Start Date: July 2006
• Actual Primary Completion Date: March 2008
• Actual Study Completion Date: March 2008

Groups and Cohorts

Group/Cohort	Intervention/treatment
1	Drug: PAZ-417; 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.
2	Drug: PAZ-417; 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.
3	Drug: PAZ-417; 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.
4	Drug: PAZ-417; 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.
5	Drug: PAZ-417; 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.
6	Drug: PAZ-417; 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.
7	Drug: PAZ-417; 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.

Outcome Measures

Biospecimen Retention:   Samples With DNA

plasma and urine

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• Sampling Method: Non-Probability Sample

Study Population

Residents of a certain town

Criteria

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.

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).

Contacts and Locations

Locations

United States, Arizona

Phoenix, Arizona, United States, 85044

Sponsors and Collaborators

Wyeth is now a wholly owned subsidiary of Pfizer

Investigators

• Study Director: Medical Monitor; Wyeth is now a wholly owned subsidiary of Pfizer

More Information

• Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
• ClinicalTrials.gov Identifier: NCT00366288 History of Changes
• Other Study ID Numbers: 3186A1-100
• First Posted: August 21, 2006
• Last Update Posted: July 10, 2009
• Last Verified: July 2009

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Healthy; Safety

Additional relevant MeSH terms:

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