A Study to Evaluate Safety, Tolerability, Plasma Drug Levels, and Cognitive Response Following Multiple Doses of a Drug in Healthy Elderly Participants.
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00832052
First received: January 27, 2009
Last updated: June 9, 2009
Last verified: June 2009
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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.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy Elderly |
Drug: PF-04447943 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) |
| 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 |
Further study details as provided by Pfizer:
Primary Outcome Measures:
- 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. ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: No ]
- Maximum plasma concentration (Cmax) [ Time Frame: 1 hour post dose day 4 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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. ] [ Designated as safety issue: No ]
| Enrollment: | 32 |
| Study Start Date: | January 2009 |
| Study Completion Date: | May 2009 |
| Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Cohort 1
Subjects will be randomized to receive either experimental drug (n=6) or placebo (n=2).
|
Drug: PF-04447943
Planned oral dose is PF-04447943, 5 mg q12 hours for 7 days.
|
|
Experimental: Cohort 2
Subjects will be randomized to receive either experimental drug (n=6) or placebo (n=2).
|
Drug: PF-04447943
Planned oral dose is PF-04447943, 15 mg q12 hours for 7 days.
|
|
Experimental: Cohort 3a
Subjects will be randomized to receive either experimental drug (n=3) or placebo (n=1).
|
Drug: 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.
|
|
Experimental: Cohort 3b
Subjects will be randomized to receive either experimental drug (n=3) or placebo (n=1).
|
Drug: 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.
|
| Experimental: Cohort 4 |
Drug: 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.
|
Eligibility| Ages Eligible for Study: | 65 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
| ClinicalTrials.gov Identifier: | NCT00832052 History of Changes |
| Other Study ID Numbers: | B0401009 |
| Study First Received: | January 27, 2009 |
| Last Updated: | June 9, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
elderly, multi-dose, safety, efficacy |
ClinicalTrials.gov processed this record on May 19, 2013