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
  Purpose

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.


Condition Intervention Phase
Healthy
Elderly
Drug: PF-04447943
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: 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

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 32
Study Start Date: January 2009
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1
Subjects will be randomized to receive either experimental drug (n=6) or placebo (n=2).
Drug: PF-04447943
Planned oral dose is PF-04447943, 5 mg q12 hours for 7 days.
Experimental: Cohort 2
Subjects will be randomized to receive either experimental drug (n=6) or placebo (n=2).
Drug: PF-04447943
Planned oral dose is PF-04447943, 15 mg q12 hours for 7 days.
Experimental: Cohort 3a
Subjects will be randomized to receive either experimental drug (n=3) or placebo (n=1).
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.
Experimental: Cohort 3b
Subjects will be randomized to receive either experimental drug (n=3) or placebo (n=1).
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.
Experimental: Cohort 4 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.

  Eligibility

Ages Eligible for Study:   65 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00832052

Locations
United States, Florida
Pfizer Investigational Site
Gainesville, Florida, United States, 32608
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00832052     History of Changes
Other Study ID Numbers: B0401009
Study First Received: January 27, 2009
Last Updated: June 9, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
elderly, multi-dose, safety, efficacy

ClinicalTrials.gov processed this record on September 22, 2014