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NCT00736528 Clinical Trial

A Phase I, Multiple Dose Study of PF-04447943 in Healthy Elderly Volunteers

Healthy Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00736528
Other study ID # B0401002
Secondary ID
Status Terminated
Phase Phase 1
First received August 15, 2008
Last updated February 23, 2009
Start date August 2008
Est. completion date September 2008

Study information
Verified date February 2009
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

To describe the safety, tolerability and pharmacokinetics of PF-04447943 after administration of multiple, ascending, oral doses to healthy elderly subjects.

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 information / eligibility
Status Terminated
Enrollment 10
Est. completion date September 2008
Est. primary completion date September 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 65 Years to 85 Years
Eligibility Inclusion Criteria:

- Healthy

- Elderly

- 65-85

Exclusion Criteria:

- Evidence or history of clinically significant unstable disease

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

Intervention

Drug:
• PF-04447943
05 mg BID for 14 days
• PF-04447943
15 mg BID for 14 days
• PF-04447943
45mg BID for 14 days
• Placebo
Placebo for 14 days

Locations
Country Name City State
United States Pfizer Investigational Site Gainesville Florida

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Primary Safety: Adverse events, change from baseline in vital signs, triplicate ECG, clinical safety laboratory endpoints 14 days Yes
Primary Pharmacokinetic endpoints will include plasma PF 04447943 AUCt, Cmax and Tmax 14 days No
Secondary Changes in cognition from baseline 14 days No
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