Expired Study
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Gainesville, Florida 32608


Purpose:

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.


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.


Study is Available At:


Original ID:

B0401009


NCT ID:

NCT00832052


Secondary ID:


Study Acronym:


Brief Title:

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


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


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

Both


Minimum Age:

65 Years


Maximum Age:

85 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Pfizer


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

5


Number of Groups:

0


Total Enrollment:

32


Enrollment Type:

Actual


Overall Contact Information

Official Name:Pfizer CT.gov Call Center
Study Director
Pfizer

Study Dates

Start Date:January 2009
Completion Date:May 2009
Completion Type:Actual
Primary Completion Date:May 2009
Primary Completion Type:Actual
Verification Date:June 2009
Last Changed Date:June 9, 2009
First Received Date:January 27, 2009

Study Outcomes

Outcome Type:Secondary Outcome
Measure: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.
Safety Issues:False
Outcome Type:Primary Outcome
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
Time Frame:For cohorts 1-3, day 7; for cohort 4, day 14
Safety Issues:False
Outcome Type:Primary Outcome
Measure: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
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Maximum plasma concentration (Cmax)
Time Frame:1 hour post dose day 4
Safety Issues:True
Outcome Type:Primary Outcome
Measure: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
Safety Issues:False
Outcome Type:Primary Outcome
Measure: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.
Safety Issues:True

Study Interventions

Intervention Type:Drug
Name:PF-04447943
Description:Planned oral dose is PF-04447943, 5 mg q12 hours for 7 days.
Arm Name:Cohort 1
Intervention Type:Drug
Name:PF-04447943
Description:Planned oral dose is PF-04447943, 15 mg q12 hours for 7 days.
Arm Name:Cohort 2
Intervention Type:Drug
Name:PF-04447943
Description: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.
Arm Name:Cohort 3a
Intervention Type:Drug
Name:PF-04447943
Description: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.
Arm Name:Cohort 3b
Intervention Type:Drug
Name:PF-04447943
Description: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.
Arm Name:Cohort 4

Study Arms

Study Arm Type:Experimental
Arm Name:Cohort 4
Study Arm Type:Experimental
Arm Name:Cohort 3b
Description:Subjects will be randomized to receive either experimental drug (n=3) or placebo (n=1).
Study Arm Type:Experimental
Arm Name:Cohort 3a
Description:Subjects will be randomized to receive either experimental drug (n=3) or placebo (n=1).
Study Arm Type:Experimental
Arm Name:Cohort 2
Description:Subjects will be randomized to receive either experimental drug (n=6) or placebo (n=2).
Study Arm Type:Experimental
Arm Name:Cohort 1
Description:Subjects will be randomized to receive either experimental drug (n=6) or placebo (n=2).

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Pfizer

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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