A Phase I, Multiple Dose Study of PF-04447943 in Healthy Elderly Volunteers
To describe the safety, tolerability and pharmacokinetics of PF-04447943 after administration of multiple, ascending, oral doses to healthy elderly subjects.
|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 In Healthy Elderly Subjects|
- Primary Safety: Adverse events, change from baseline in vital signs, triplicate ECG, clinical safety laboratory endpoints [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
- Pharmacokinetic endpoints will include plasma PF 04447943 AUCt, Cmax and Tmax [ Time Frame: 14 days ] [ Designated as safety issue: No ]
- Changes in cognition from baseline [ Time Frame: 14 days ] [ Designated as safety issue: No ]
|Study Start Date:||August 2008|
|Study Completion Date:||September 2008|
|Primary Completion Date:||September 2008 (Final data collection date for primary outcome measure)|
|Experimental: PF-04447943 05 mg dose||
05 mg BID for 14 days
|Experimental: PF-04447943 15 mg dose||
15 mg BID for 14 days
|Experimental: PF-04447943 45 mg dose||
45mg BID for 14 days
|Placebo Comparator: Placebo||
Placebo for 14 days
Additional Study Purpose Details: Phase I safety and pharmacokinetics study.
The study was terminated on 11/12/2008. There were no safety findings in this trial that resulted in the decision to terminate the trial. The study was closed in order to change the amount of drug that subjects would take and to shorten the number of days that the drug would be taken in a new study.