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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.

Last updated on November 14, 2019

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Study Location
Pfizer Investigational Site
Gainesville, Florida, 32608 United States
Contact
1-800-718-1021
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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Descriptive Information
Brief Title  ICMJE A Study to Evaluate Safety, Tolerability, Plasma Drug Levels, and Cognitive Response Following Multiple Doses of a Drug in Healthy Elderly Participants.
Official Title  ICMJE 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
Brief SummaryEvaluate the safety and tolerability of PF-04447943 after administration of multiple doses in healthy elderly participants. Evaluate plasma drug levels and effects on cognition.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Condition  ICMJE
  • Healthy
  • Elderly
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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
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  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 19, 2009)
32
Original Estimated Enrollment  ICMJE
 (submitted: January 27, 2009)
40
Actual Study Completion Date  ICMJE May 2009
Actual Primary Completion DateMay 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 65 Years to 85 Years   (Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00832052
Other Study ID Numbers  ICMJE B0401009
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyDirector, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateJune 2009

ICMJE     Data element required by the

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

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

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1-800-718-1021

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