- ICH GCP
- US Clinical Trials Registry
- 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.
June 9, 2009 updated by: Pfizer
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
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 Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
32
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Gainesville, Florida, United States, 32608
- Pfizer Investigational Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years to 85 years (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cohort 4
|
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.
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.
|
Experimental: Cohort 1
Subjects will be randomized to receive either experimental drug (n=6) or placebo (n=2).
|
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.
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.
|
Experimental: Cohort 2
Subjects will be randomized to receive either experimental drug (n=6) or placebo (n=2).
|
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.
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.
|
Experimental: Cohort 3a
Subjects will be randomized to receive either experimental drug (n=3) or placebo (n=1).
|
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.
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.
|
Experimental: Cohort 3b
Subjects will be randomized to receive either experimental drug (n=3) or placebo (n=1).
|
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome 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
Time Frame: For cohorts 1-3, up to 17 days; for cohort 4, up to 24 days.
|
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
|
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
|
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
|
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
|
For cohorts 1-3, day 7; for cohort 4, day 14
|
Secondary Outcome Measures
Outcome 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
Time Frame: For cohorts 1-3, up to 17 days; for cohort 4, up to 24 days.
|
For cohorts 1-3, up to 17 days; for cohort 4, up to 24 days.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2009
Primary Completion (Actual)
May 1, 2009
Study Completion (Actual)
May 1, 2009
Study Registration Dates
First Submitted
January 27, 2009
First Submitted That Met QC Criteria
January 27, 2009
First Posted (Estimate)
January 29, 2009
Study Record Updates
Last Update Posted (Estimate)
June 12, 2009
Last Update Submitted That Met QC Criteria
June 9, 2009
Last Verified
June 1, 2009
More Information
Terms related to this study
Other Study ID Numbers
- B0401009
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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