Clinical trial NCT00832052: A Study to Evaluate Safety, Tolerability, Plasma Drug Levels, and Cognitive Response Following Multiple Doses of a Drug in Healthy Elderly Participants.
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Elderly
Keywords: elderly, multi-dose, safety, efficacy
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-01-29
Enrollment: 32
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.


Eligibility 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.

Primary outcomes:
measure: Safety endpoints include evaluation of adverse events, change from baseline in vital signs, triplicate and single ECGs, and clinical safety laboratory tests
timeFrame: For cohorts 1-3, up to 17 days; for cohort 4, up to 24 days.
measure: Pharmacokinetic endpoints include plasma PF-04447943 area udner the curve (AUCt ), maximum plasma concentration (Cmax) and time of maximum plasma concentration (Tmax)
timeFrame: For cohorts 1-3, days 1 and 7; for cohort 4, days 1 and 14
measure: Maximum plasma concentration (Cmax)
timeFrame: 1 hour post dose day 4
measure: Minimum plasma concentration ((Ctrough)
timeFrame: For cohorts 1-3, days 2, 3, 4, and 7; for cohort 4, days 2, 3, 4, 12, and 13
measure: 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
timeFrame: For cohorts 1-3, day 7; for cohort 4, day 14
Secondary outcomes:
measure: CogState Phase 1 Battery, to include Detect, Identify, One-Card Learning, Groton Maza Learning, Continuous Paired Associated Learning Test, and Composite Cognitive Score
timeFrame: For cohorts 1-3, up to 17 days; for cohort 4, up to 24 days.
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Pfizer Investigational Site
state: Florida
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: