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A Study To Observe Safety And Blood Concentrations Of PF-04995274 During And Following the Administration of Multiple Doses Of PF-04995274 In Healthy Adult And Healthy Elderly Volunteers.

Last updated on November 14, 2019

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Overland Park, Kansas, 66211 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-85 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- For Healthy adult volunteers: healthy male and/or female subjects of non child
bearing potential between the ages of 18 and 55 years, inclusive. (Healthy is defined
as no clinically relevant abnormalities identified by a detailed medical history,
full physical examination, including blood pressure and heart rate measurement, 12
lead ECG and clinical laboratory tests.)

- For Healthy Elderly volunteers: healthy male and/or female subjects of non child
bearing potential between the ages of 65 and 85 years, inclusive. Subjects must be in
reasonably good health as determined by the investigator based on a detailed medical
history, full physical examination (including blood pressure and pulse rate
measurement), 12 lead ECG and clinical laboratory tests. Subjects with mild, chronic,
stable disease (eg, controlled hypertension, non-insulin dependent diabetes,
osteoarthritis) may be enrolled if deemed medically prudent by the investigator. In
order to ensure an age range relevant to the Alzheimer's Disease (AD) population, no
more than 30% of subjects enrolled in any cohort may be less than 70 years of age.

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

- Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or
allergic disease (including drug allergies, but excluding untreated, asymptomatic,
seasonal allergies at time of dosing).

NCT01169714
Pfizer
Completed
A Study To Observe Safety And Blood Concentrations Of PF-04995274 During And Following the Administration of Multiple Doses Of PF-04995274 In Healthy Adult And Healthy Elderly Volunteers.

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Descriptive Information
Brief Title  ICMJE A Study To Observe Safety And Blood Concentrations Of PF-04995274 During And Following the Administration of Multiple Doses Of PF-04995274 In Healthy Adult And 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-04995274 In Healthy Adult And Healthy Elderly Subjects
Brief SummaryThis study is designed to observe the safety and blood concentrations of PF-04995274 during and following the administration of multiple doses of PF-04995274 for a duration of 14 days, in healthy adult and healthy elderly.
Detailed DescriptionTo examine the safety and pharmacokinetics of PF-04995274 in healthy adult and healthy elderly subjects after multiple doses.
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
Intervention  ICMJE
  • Drug: 0.1 mg PF-04995274
    0.1 mg PF-04995274, qd, for 14 days or placebo
  • Drug: 1 mg PF-04995274
    1 mg PF-04995274, qd, for 14 days or placebo
  • Drug: 10 mg PF-04995274
    10 mg PF-04995274, qd, for 14 days or placebo
  • Drug: 15 mg PF-04995274
    15 mg PF-04995274, qd, for 14 days or placebo
  • Drug: 1.0 mg PF-04995274
    1.0 mg PF-04995274, qd, for 14 days or placebo
Study Arms  ICMJE
  • Experimental: Dosing Healthy Adult
    Ascending Doses in Healthy Adult Volunteers
    Interventions:
    • Drug: 0.1 mg PF-04995274
    • Drug: 1 mg PF-04995274
    • Drug: 10 mg PF-04995274
    • Drug: 15 mg PF-04995274
  • Experimental: Dosing Healthy Elderly
    Dosing in Healthy Elderly volunteers
    Interventions:
    • Drug: 1.0 mg PF-04995274
    • Drug: 15 mg PF-04995274
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 Completed
Actual Enrollment  ICMJE
 (submitted: January 19, 2011)
60
Original Estimated Enrollment  ICMJE
 (submitted: July 22, 2010)
70
Actual Study Completion Date  ICMJE December 2010
Actual Primary Completion DateDecember 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • For Healthy adult volunteers: healthy male and/or female subjects of non child bearing potential between the ages of 18 and 55 years, inclusive. (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and heart rate measurement, 12 lead ECG and clinical laboratory tests.)
  • For Healthy Elderly volunteers: healthy male and/or female subjects of non child bearing potential between the ages of 65 and 85 years, inclusive. Subjects must be in reasonably good health as determined by the investigator based on a detailed medical history, full physical examination (including blood pressure and pulse rate measurement), 12 lead ECG and clinical laboratory tests. Subjects with mild, chronic, stable disease (eg, controlled hypertension, non-insulin dependent diabetes, osteoarthritis) may be enrolled if deemed medically prudent by the investigator. In order to ensure an age range relevant to the Alzheimer's Disease (AD) population, no more than 30% of subjects enrolled in any cohort may be less than 70 years of age.

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 85 Years   (Adult, 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 NCT01169714
Other Study ID Numbers  ICMJE B1661003
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyDirector, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateJanuary 2011

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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