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Study Evaluating PAZ-417 in Healthy Young/Elderly

Last updated on April 10, 2018

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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Study Evaluating PAZ-417 in Healthy Young/Elderly
Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PAZ-417 Administered Orally to Healthy Young and Healthy Elderly Subjects
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.
Not Provided
Observational
Observational Model: Cohort
Not Provided
Retention:   Samples With DNA
Description:
plasma and urine
Non-Probability Sample
Residents of a certain town
Alzheimer Disease
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.
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
56
March 2008
March 2008   (Final data collection date for primary outcome measure)

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).
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00366288
3186A1-100
Not Provided
Not Provided
Not Provided
Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
July 2009

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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