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

This study has been terminated.
(See Detailed Description for termination reason.)
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00736528
First received: August 15, 2008
Last updated: February 23, 2009
Last verified: February 2009
  Purpose

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


Condition Intervention Phase
Healthy
Elderly
Drug: PF-04447943
Drug: Placebo
Phase 1

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

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Primary Safety: Adverse events, change from baseline in vital signs, triplicate ECG, clinical safety laboratory endpoints [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
  • Pharmacokinetic endpoints will include plasma PF 04447943 AUCt, Cmax and Tmax [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in cognition from baseline [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: August 2008
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PF-04447943 05 mg dose Drug: PF-04447943
05 mg BID for 14 days
Experimental: PF-04447943 15 mg dose Drug: PF-04447943
15 mg BID for 14 days
Experimental: PF-04447943 45 mg dose Drug: PF-04447943
45mg BID for 14 days
Placebo Comparator: Placebo Drug: Placebo
Placebo for 14 days

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.

  Eligibility

Ages Eligible for Study:   65 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy
  • Elderly
  • 65-85

Exclusion Criteria:

  • Evidence or history of clinically significant unstable disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00736528

Locations
United States, Florida
Pfizer Investigational Site
Gainesville, Florida, United States, 32608
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00736528     History of Changes
Other Study ID Numbers: B0401002
Study First Received: August 15, 2008
Last Updated: February 23, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
safety, tolerability, pharmacokinetics, cognition

ClinicalTrials.gov processed this record on July 29, 2014