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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:
ClinicalTrials.gov Identifier:
NCT00736528
First Posted: August 18, 2008
Last Update Posted: February 25, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Pfizer
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 ]
  • Pharmacokinetic endpoints will include plasma PF 04447943 AUCt, Cmax and Tmax [ Time Frame: 14 days ]

Secondary Outcome Measures:
  • Changes in cognition from baseline [ Time Frame: 14 days ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   65 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy
  • Elderly
  • 65-85

Exclusion Criteria:

  • Evidence or history of clinically significant unstable disease
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00736528     History of Changes
Other Study ID Numbers: B0401002
First Submitted: August 15, 2008
First Posted: August 18, 2008
Last Update Posted: February 25, 2009
Last Verified: February 2009

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