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Trial record 1 of 1 for:    NCT00832052
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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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ClinicalTrials.gov Identifier: NCT00832052
Recruitment Status : Completed
First Posted : January 29, 2009
Last Update Posted : June 12, 2009
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE January 27, 2009
First Posted Date  ICMJE January 29, 2009
Last Update Posted Date June 12, 2009
Study Start Date  ICMJE January 2009
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 19, 2009)
  • Safety endpoints include evaluation of adverse events, change from baseline in vital signs, triplicate and single ECGs, and clinical safety laboratory tests [ Time Frame: For cohorts 1-3, up to 17 days; for cohort 4, up to 24 days. ]
  • Pharmacokinetic endpoints include plasma PF-04447943 area udner the curve (AUCt ), maximum plasma concentration (Cmax) and time of maximum plasma concentration (Tmax) [ Time Frame: For cohorts 1-3, days 1 and 7; for cohort 4, days 1 and 14 ]
  • Maximum plasma concentration (Cmax) [ Time Frame: 1 hour post dose day 4 ]
  • Minimum plasma concentration ((Ctrough) [ Time Frame: For cohorts 1-3, days 2, 3, 4, and 7; for cohort 4, days 2, 3, 4, 12, and 13 ]
  • Fraction of the total dose excreted in urine (Fe) and the renal clearance (CLR), and, if the data permit, half-life and the observed exposure accumulation ratio (Ro), and fluctuation index (Cmax: Cmin ratio) following multiple doses [ Time Frame: For cohorts 1-3, day 7; for cohort 4, day 14 ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 27, 2009)
  • Safety endpoints include evaluation of adverse events, change from baseline in vital signs, triplicate and single ECGs, and clinical safety laboratory tests [ Time Frame: For cohorts 1-3, up to 17 days; for cohort 4, up to 24 days. ]
  • Pharmacokinetic endpoints include plasma PF-04447943 area under the curve (AUCt), maximum plasma concentration (Cmax) and time of maximum plasma concentration (Tmax) [ Time Frame: For cohorts 1-3, days 1 and 7; for cohort 4, days 1 and 14 ]
  • Maximum plasma concentration (Cmax) [ Time Frame: 1 hour post dose day 4 ]
  • Minimum plasma concentration (Ctrough) [ Time Frame: For cohorts 1-3, days 2, 3, 4, and 7; for cohort 4, days 2, 3, 4, 12, and 13 ]
  • Fraction of the total dose excreted in urine (Fe) and the renal clearance (CLR), and, if the data permit, half-life and the observed exposure accumulation ratio (Ro), and fluctuation index (Cmax: Cmin ratio) following multiple doses [ Time Frame: For cohorts 1-3, day 7; for cohort 4, day 14 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 27, 2009)
CogState Phase 1 Battery, to include Detect, Identify, One-Card Learning, Groton Maza Learning, Continuous Paired Associated Learning Test, and Composite Cognitive Score [ Time Frame: For cohorts 1-3, up to 17 days; for cohort 4, up to 24 days. ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Summary 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.
Detailed Description Not 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 Date May 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 Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP