Elderly, Healthy
Conditions
Keywords
safety, tolerability, pharmacokinetics, cognition
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.
Interventions
DRUGPF-04447943
05 mg BID for 14 days
DRUGPlacebo
Placebo for 14 days
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
65 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy * Elderly * 65-85
Exclusion criteria
* Evidence or history of clinically significant unstable disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Changes in cognition from baseline | 14 days |
Countries
United States
Outcome results
None listed