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Study Evaluating PAZ-417 in Healthy Young/Elderly

Last updated on April 2, 2020

FOR MORE INFORMATION
Study Location
Phoenix, Arizona, 85044 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Alzheimer Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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).

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

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).

NCT00366288
Pfizer
Completed
Study Evaluating PAZ-417 in Healthy Young/Elderly

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Descriptive Information
Brief Title Study Evaluating PAZ-417 in Healthy Young/Elderly
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
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
plasma and urine
Sampling Method Non-Probability Sample
Study Population Residents of a certain town
Condition Alzheimer Disease
Intervention 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.
Study Groups/Cohorts
  • 1
    Intervention: Drug: PAZ-417
  • 2
    Intervention: Drug: PAZ-417
  • 3
    Intervention: Drug: PAZ-417
  • 4
    Intervention: Drug: PAZ-417
  • 5
    Intervention: Drug: PAZ-417
  • 6
    Intervention: Drug: PAZ-417
  • 7
    Intervention: Drug: PAZ-417
Publications * Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Estimated Enrollment
 (submitted: December 20, 2007)
56
Original Enrollment Not Provided
Actual Study Completion Date March 2008
Actual Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Eligibility 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).
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00366288
Other Study ID Numbers 3186A1-100
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Study Sponsor Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators Not Provided
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date July 2009

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

Call Now