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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00832052

Enrollment

Registered

2009-01-29

Start date

2009-01-31

Completion date

2009-05-31

Last updated

2009-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Elderly, Healthy

Keywords

elderly, multi-dose, safety, efficacy

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.

Interventions

DRUGPF-04447943

Planned oral dose is PF-04447943, 5 mg q12 hours for 7 days.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

65 Years to 85 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026