You are here

A Study to Evaluate Safety, Toleration and Time Course of Plasma Concentration of Multiple Oral Doses of PF-06273340 in Healthy Subjects of Two AgeGroups, Aged 18-55 Years (Group 1) and Aged 56-75 Years (Group 2)

Last updated on November 13, 2019

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 (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 tests).

- For Group 2 specific: Healthy male and/or female subjects of non-childbearing
potential between the ages of 56 and 75 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, osteoarthritis) may be enrolled if deemed medically prudent by the
investigator. In order to ensure an age range relevant to the osteoarthritis (OA)
population, 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

- 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 the time of dosing).

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

NCT01934738
Pfizer
Completed
A Study to Evaluate Safety, Toleration and Time Course of Plasma Concentration of Multiple Oral Doses of PF-06273340 in Healthy Subjects of Two AgeGroups, Aged 18-55 Years (Group 1) and Aged 56-75 Years (Group 2)

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

Descriptive Information
Brief Title  ICMJE A Study to Evaluate Safety, Toleration and Time Course of Plasma Concentration of Multiple Oral Doses of PF-06273340 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-06273340 in Healthy Subjects
Brief SummaryThe purpose of this study is to investigate safety, toleration and time course of plasma concentration of multiple oral doses of PF-06273340 for 14 days in healthy subjects of two age groups, aged 18-55 years (Group 1) and aged 56-75 years (Group 2)
Detailed DescriptionNot 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-06273340
    Tablets, 100 mg TID, 14 days
  • Drug: Placebo
    Tablets, TID, 14 days
  • Drug: PF-06273340
    Tablets, to be decided dose, TID or titration, 14 days
  • Drug: Placebo
    Tablets, TID or titration, 14 days
Study Arms  ICMJE
  • Experimental: Group 1: Cohort 1
    Interventions:
    • Drug: PF-06273340
    • Drug: Placebo
  • Experimental: Group 1: Cohort 2
    Interventions:
    • Drug: PF-06273340
    • Drug: Placebo
  • Experimental: Group 1: Cohort 3
    Interventions:
    • Drug: PF-06273340
    • Drug: Placebo
  • Experimental: Group 2: Cohort 4
    Interventions:
    • Drug: PF-06273340
    • Drug: Placebo
  • Experimental: Group 1: Cohort 5
    Interventions:
    • Drug: PF-06273340
    • Drug: Placebo
  • Experimental: Group 2: Cohort 6
    Interventions:
    • Drug: PF-06273340
    • 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 Completed
Actual Enrollment  ICMJE
 (submitted: March 9, 2014)
52
Original Estimated Enrollment  ICMJE
 (submitted: August 30, 2013)
60
Actual Study Completion Date  ICMJE March 2014
Actual Primary Completion DateMarch 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 (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 tests).
  • For Group 2 specific: Healthy male and/or female subjects of non-childbearing potential between the ages of 56 and 75 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, osteoarthritis) may be enrolled if deemed medically prudent by the investigator. In order to ensure an age range relevant to the osteoarthritis (OA) population, 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:

  • 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 the time of dosing).
  • 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 NCT01934738
Other Study ID Numbers  ICMJE B5261002
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateMarch 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

BY EMAIL

Contact

[email protected]

Call Now