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A Study to Evaluate Safety, Tolerability, Plasma Drug Levels, and Cognitive Response Following Multiple Doses of a Drug in Healthy Elderly Participants.

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NCT00832052

Last updated on May 10, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Gainesville, Florida, 32608 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy, Elderly
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
65-85 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Healthy male and/or female subjects.

- Subjects must be in reasonably good health as determined by the investigator based on
medical history, full physical examination (including blood pressure and pulse rate
measurement), 12 lead ECG and clinical laboratory tests.

- Subjects with mild, chronic, stable disease (eg, controlled hypertension, non-insulin
dependent diabetes, osteoarthritis may be enrolled if deemed medically prudent by the
investigator.

- Subjects taking daily prescription or non-prescription medications for management of
acceptable chronic medical conditions must be on a stable dose.

- Body Mass Index (BMI) between 18 to 30 kg/m2, inclusive; and a total body weight >50
kg (110 lbs).

- Creatinine clearance greater than 30 mL/min using the Cockcroft-Gault method.

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

- Subjects with evidence or history of clinically significant hematological, renal,
endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric,
neurologic, immunologic, or allergic disease.

- Use of tobacco or any form of nicotine in the past 6 months.

- Greater than 7 drinks of alcohol per week for women, and greater than 14 drinks of
alcohol per week for men.

NCT00832052
Pfizer
Completed
A Study to Evaluate Safety, Tolerability, Plasma Drug Levels, and Cognitive Response Following Multiple Doses of a Drug in Healthy Elderly Participants.

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[email protected]

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A Study to Evaluate Safety, Tolerability, Plasma Drug Levels, and Cognitive Response Following Multiple Doses of a Drug in Healthy Elderly Participants.
An Investigator And Subject-Blind Phase 1 Study To Characterize The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Multiple Doses Of PF-04447943 Up To An Exposure Cap In Healthy Elderly Subjects
Evaluate the safety and tolerability of PF-04447943 after administration of multiple doses in healthy elderly participants. Evaluate plasma drug levels and effects on cognition.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
  • Healthy
  • Elderly
  • Drug: PF-04447943
    Planned oral dose is PF-04447943, 5 mg q12 hours for 7 days.
  • Drug: PF-04447943
    Planned oral dose is PF-04447943, 15 mg q12 hours for 7 days.
  • Drug: PF-04447943
    Planned oral dose is PF-04447943, 35 mg q12 hours for 7 days. Actual dose may be adjusted based on pharmacokinetic and other data from prior dose cohorts.
  • Drug: PF-04447943
    Planned oral dose is PF-04447943, 35 mg q12 hours for 14 days. Actual dose may be adjusted downward based on pharmacokinetic and other data from prior dose cohorts.
  • Experimental: Cohort 1
    Subjects will be randomized to receive either experimental drug (n=6) or placebo (n=2).
    Intervention: Drug: PF-04447943
  • Experimental: Cohort 2
    Subjects will be randomized to receive either experimental drug (n=6) or placebo (n=2).
    Intervention: Drug: PF-04447943
  • Experimental: Cohort 3a
    Subjects will be randomized to receive either experimental drug (n=3) or placebo (n=1).
    Intervention: Drug: PF-04447943
  • Experimental: Cohort 3b
    Subjects will be randomized to receive either experimental drug (n=3) or placebo (n=1).
    Intervention: Drug: PF-04447943
  • Experimental: Cohort 4
    Intervention: Drug: PF-04447943
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
May 2009
May 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy male and/or female subjects.
  • Subjects must be in reasonably good health as determined by the investigator based on medical history, full physical examination (including blood pressure and pulse rate measurement), 12 lead ECG and clinical laboratory tests.
  • Subjects with mild, chronic, stable disease (eg, controlled hypertension, non-insulin dependent diabetes, osteoarthritis may be enrolled if deemed medically prudent by the investigator.
  • Subjects taking daily prescription or non-prescription medications for management of acceptable chronic medical conditions must be on a stable dose.
  • Body Mass Index (BMI) between 18 to 30 kg/m2, inclusive; and a total body weight >50 kg (110 lbs).
  • Creatinine clearance greater than 30 mL/min using the Cockcroft-Gault method.

Exclusion Criteria:

  • Subjects with evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, immunologic, or allergic disease.
  • Use of tobacco or any form of nicotine in the past 6 months.
  • Greater than 7 drinks of alcohol per week for women, and greater than 14 drinks of alcohol per week for men.
Sexes Eligible for Study: All
65 Years to 85 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00832052
B0401009
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 2009

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

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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1-800-718-1021

BY EMAIL

Contact

[email protected]



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