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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
DOUBLE
Enrollment
32
Planned oral dose is PF-04447943, 5 mg q12 hours for 7 days.
Planned oral dose is PF-04447943, 15 mg q12 hours for 7 days.
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.
Pfizer Investigational Site
Gainesville, Florida, United States
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
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.
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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.
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.