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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00832052
First received: January 27, 2009
Last updated: June 9, 2009
Last verified: June 2009

January 27, 2009
June 9, 2009
January 2009
May 2009   (final data collection date for primary outcome measure)
  • 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. ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • Maximum plasma concentration (Cmax) [ Time Frame: 1 hour post dose day 4 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00832052 on ClinicalTrials.gov Archive Site
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. ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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.
Both
65 Years to 85 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00832052
B0401009
No
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