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

NCT00736528

Last updated date
Study Location
Pfizer Investigational Site
Gainesville, Florida, 32608, United States
Contact
1-800-718-1021

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy, Elderly
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
65-85 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Healthy

- Elderly

- 65-85

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Evidence or history of clinically significant unstable disease

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Healthy, ElderlyA Phase I, Multiple Dose Study of PF-04447943 in Healthy Elderly Volunteers NCT00736528
  1. Gainesville, Florida
ALL GENDERS
65 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Phase I, Multiple Dose Study of PF-04447943 in Healthy Elderly Volunteers
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Condition  ICMJE
  • Healthy
  • Elderly
Intervention  ICMJE
  • Drug: PF-04447943
    05 mg BID for 14 days
  • Drug: PF-04447943
    15 mg BID for 14 days
  • Drug: PF-04447943
    45mg BID for 14 days
  • Drug: Placebo
    Placebo for 14 days
Study Arms  ICMJE
  • Experimental: PF-04447943 05 mg dose
    Intervention: Drug: PF-04447943
  • Experimental: PF-04447943 15 mg dose
    Intervention: Drug: PF-04447943
  • Experimental: PF-04447943 45 mg dose
    Intervention: Drug: PF-04447943
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: January 29, 2009)
10
Original Estimated Enrollment  ICMJE
 (submitted: August 15, 2008)
40
Actual Study Completion Date  ICMJE September 2008
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy
  • Elderly
  • 65-85

Exclusion Criteria:

  • Evidence or history of clinically significant unstable disease
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 65 Years to 85 Years   (Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00736528
Other Study ID Numbers  ICMJE B0401002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP