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
Overview
- Phase
- Phase 1
- Intervention
- PF-04447943
- Conditions
- Healthy
- Sponsor
- Pfizer
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Primary Safety: Adverse events, change from baseline in vital signs, triplicate ECG, clinical safety laboratory endpoints
- Status
- Terminated
- Last Updated
- 17 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •Evidence or history of clinically significant unstable disease
Arms & Interventions
PF-04447943 05 mg dose
Intervention: PF-04447943
PF-04447943 15 mg dose
Intervention: PF-04447943
PF-04447943 45 mg dose
Intervention: PF-04447943
Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Primary Safety: Adverse events, change from baseline in vital signs, triplicate ECG, clinical safety laboratory endpoints
Time Frame: 14 days
Pharmacokinetic endpoints will include plasma PF 04447943 AUCt, Cmax and Tmax
Time Frame: 14 days
Secondary Outcomes
- Changes in cognition from baseline(14 days)