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

Pfizer

Status and phase: Terminated; Phase 1

Conditions: Healthy; Elderly

Treatments: Drug: PF-04447943; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00736528

B0401002

Details and patient eligibility

About

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

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 65 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy
• Elderly
• 65-85

Exclusion criteria

• Evidence or history of clinically significant unstable disease

Trial design

10 participants in 4 patient groups, including a placebo group

PF-04447943 05 mg dose

Experimental group

Treatment:

Drug: PF-04447943

Drug: PF-04447943

Drug: PF-04447943

PF-04447943 15 mg dose

Experimental group

Treatment:

Drug: PF-04447943

Drug: PF-04447943

Drug: PF-04447943

PF-04447943 45 mg dose

Experimental group

Treatment:

Drug: PF-04447943

Drug: PF-04447943

Drug: PF-04447943

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo