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Study Evaluating PAZ-417 in Healthy Young/Elderly

Last updated on March 14, 2019

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.
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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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