A Study to Evaluate Safety, Tolerability, Plasma Drug Levels, and Cognitive Response Following Multiple Doses of a Drug in Healthy Elderly Participants.
- Registration Number
- NCT00832052
- Lead Sponsor
- Pfizer
- 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 available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 3b PF-04447943 Subjects will be randomized to receive either experimental drug (n=3) or placebo (n=1). Cohort 4 PF-04447943 - Cohort 2 PF-04447943 Subjects will be randomized to receive either experimental drug (n=6) or placebo (n=2). Cohort 3a PF-04447943 Subjects will be randomized to receive either experimental drug (n=3) or placebo (n=1). Cohort 1 PF-04447943 Subjects will be randomized to receive either experimental drug (n=6) or placebo (n=2).
- Primary Outcome Measures
Name Time Method Safety endpoints include evaluation of adverse events, change from baseline in vital signs, triplicate and single ECGs, and clinical safety laboratory tests 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) For cohorts 1-3, days 1 and 7; for cohort 4, days 1 and 14 Maximum plasma concentration (Cmax) 1 hour post dose day 4 Minimum plasma concentration ((Ctrough) 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 For cohorts 1-3, day 7; for cohort 4, day 14
- Secondary Outcome Measures
Name Time Method CogState Phase 1 Battery, to include Detect, Identify, One-Card Learning, Groton Maza Learning, Continuous Paired Associated Learning Test, and Composite Cognitive Score For cohorts 1-3, up to 17 days; for cohort 4, up to 24 days.
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇺🇸Gainesville, Florida, United States