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A Study to Evaluate Safety, Toleration and Time Course of Plasma Concentration of Multiple Oral Doses of PF-06372865 in Healthy Subjects of Two AgeGroups, Aged 18-55 Years (Group 1) and Aged 56-75 Years (Group 2)

Last updated on January 24, 2020

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Brussels, , B-1070 Belgium
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
18-75 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- For Group 1 specific: Healthy male and/or female subjects of non-childbearing
potential between the ages of 18 and 55 years, inclusive at Screening. Healthy is
defined as no clinically relevant abnormalities identified by a detailed medical
history, full physical examination, including blood pressure and pulse rate
measurement, 12-lead ECG and clinical laboratory.

- For Group 2 specific: Male and/or female subjects of non-childbearing potential
between the ages of 56 and 75 years, inclusive at Screening. 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, osteoarthritis) may be enrolled if deemed medically prudent by
the Investigator. At least 50% of the subjects enrolled in these cohorts must be 60
years of age and above at Screening.

- For Group 2 specific: Subjects taking daily prescription or non-prescription
medications for management of acceptable chronic medical conditions must be on a
stable dose of these, as defined by non change in dose for the 3 months prior to the
first dose of study medication and no planned changes during the conduct of the
study.

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

- For Group 1 specific: 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).

- For Group 2 specific : Evidence or history of unstable disease or moderate to severe
conditions which would, in the Investigator's opinion, interfere with the study
evaluations or impact on the safety of participating subjects, such as orthostatic
hypotension.

- Subjects with history of sleep apnea

- Any condition possibly affecting drug absorption (eg, gastrectomy).

NCT02070289
Pfizer
Completed
A Study to Evaluate Safety, Toleration and Time Course of Plasma Concentration of Multiple Oral Doses of PF-06372865 in Healthy Subjects of Two AgeGroups, Aged 18-55 Years (Group 1) and Aged 56-75 Years (Group 2)

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Descriptive Information
Brief Title  ICMJE A Study to Evaluate Safety, Toleration and Time Course of Plasma Concentration of Multiple Oral Doses of PF-06372865 in Healthy Subjects of Two AgeGroups, Aged 18-55 Years (Group 1) and Aged 56-75 Years (Group 2)
Official Title  ICMJE A Phase 1 Double Blind (3rd Party Open) Randomized, Placebo Controlled, Dose Escalation Study To Investigate The Safety, Tolerability And Pharmacokinetics Of Repeat Doses Of Pf-06372865 In Subjects Aged 18-55 (Group 1) And 56-75 Years (Group 2)
Brief Summary The purpose of this study is to investigate safety, toleration and time course of plasma concentration of multiple oral doses of PF-06372865 for 14 days in healthy subjects of two age groups, 18-55 years (Group 1) and 56-75 years (Group 2).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: PF-06372865
    Tablets, 2.5 mg BID, 14 days
  • Drug: Placebo
    Tablets, BID, 14 days
  • Drug: PF-06372865
    Tablets, to be decided dose, BID or titration, 14 days
  • Drug: Placebo
    Tablets, BID or titration, 14 days
Study Arms  ICMJE
  • Experimental: Group 1: Cohort 1
    Interventions:
    • Drug: PF-06372865
    • Drug: Placebo
  • Experimental: Group 1: Cohort 2
    Interventions:
    • Drug: PF-06372865
    • Drug: Placebo
  • Experimental: Group 1: Cohort 3
    Interventions:
    • Drug: PF-06372865
    • Drug: Placebo
  • Experimental: Group 2: Cohort 4
    Interventions:
    • Drug: PF-06372865
    • Drug: Placebo
  • Experimental: Group 1 or 2: Cohort 5
    Interventions:
    • Drug: PF-06372865
    • Drug: Placebo
  • Experimental: Group 1 or 2: Cohort 6
    Intervention: Drug: PF-06372865
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: August 15, 2014)
50
Original Estimated Enrollment  ICMJE
 (submitted: February 20, 2014)
60
Actual Study Completion Date  ICMJE July 2014
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • For Group 1 specific: Healthy male and/or female subjects of non-childbearing potential between the ages of 18 and 55 years, inclusive at Screening. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory.
  • For Group 2 specific: Male and/or female subjects of non-childbearing potential between the ages of 56 and 75 years, inclusive at Screening. 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, osteoarthritis) may be enrolled if deemed medically prudent by the Investigator. At least 50% of the subjects enrolled in these cohorts must be 60 years of age and above at Screening.
  • For Group 2 specific: Subjects taking daily prescription or non-prescription medications for management of acceptable chronic medical conditions must be on a stable dose of these, as defined by non change in dose for the 3 months prior to the first dose of study medication and no planned changes during the conduct of the study.

Exclusion Criteria:

  • For Group 1 specific: 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).
  • For Group 2 specific : Evidence or history of unstable disease or moderate to severe conditions which would, in the Investigator's opinion, interfere with the study evaluations or impact on the safety of participating subjects, such as orthostatic hypotension.
  • Subjects with history of sleep apnea
  • Any condition possibly affecting drug absorption (eg, gastrectomy).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 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 Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02070289
Other Study ID Numbers  ICMJE B7431002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date August 2014

ICMJE     Data element required by the

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

FOR MORE INFORMATION

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

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]

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