A Study to Evaluate Safety, Tolerability, Plasma Drug Levels, and Cognitive Response Following Multiple Doses of a Drug in Healthy Elderly Participants.

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00832052
• Other study ID #: B0401009
• Status: Completed
• Phase: Phase 1
• First received: January 27, 2009
• Last updated: June 9, 2009
• Start date: January 2009
• Est. completion date: May 2009

Study information

• Verified date: June 2009
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Elderly
• Healthy

Intervention

Drug:
• PF-04447943
Planned oral dose is PF-04447943, 5 mg q12 hours for 7 days.
• PF-04447943
Planned oral dose is PF-04447943, 15 mg q12 hours for 7 days.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Yes
Primary	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	No
Primary	Maximum plasma concentration (Cmax)		1 hour post dose day 4	Yes
Primary	Minimum plasma concentration ((Ctrough)		For cohorts 1-3, days 2, 3, 4, and 7; for cohort 4, days 2, 3, 4, 12, and 13	No
Primary	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	No
Secondary	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.	No

External Links

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