A Phase I, Multiple Dose Study of PF-04447943 in Healthy Elderly Volunteers
- Registration Number
- NCT00736528
- Lead Sponsor
- Pfizer
- Brief Summary
To describe the safety, tolerability and pharmacokinetics of PF-04447943 after administration of multiple, ascending, oral doses to healthy elderly subjects.
- Detailed Description
Additional Study Purpose Details: Phase I safety and pharmacokinetics study.
Detailed Description:
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 10
Inclusion Criteria
- Healthy
- Elderly
- 65-85
Exclusion Criteria
- Evidence or history of clinically significant unstable disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PF-04447943 05 mg dose PF-04447943 - Placebo Placebo - PF-04447943 15 mg dose PF-04447943 - PF-04447943 45 mg dose PF-04447943 -
- Primary Outcome Measures
Name Time Method Primary Safety: Adverse events, change from baseline in vital signs, triplicate ECG, clinical safety laboratory endpoints 14 days Pharmacokinetic endpoints will include plasma PF 04447943 AUCt, Cmax and Tmax 14 days
- Secondary Outcome Measures
Name Time Method Changes in cognition from baseline 14 days
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇺🇸Gainesville, Florida, United States