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A Healthy Volunteer Trial to Gain Information About the Blood Concentrations of PF-06412562 After Oral Administration of a Modified Release Formulation in Fasted and Fed Conditions

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NCT02201511

Last updated on April 3, 2020
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Study Location
Pfizer Clinical Research Unit
Brussels, , B-1070 Belgium
See other locations
Contact
1-800-718-1021
[email protected]
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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
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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).

- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110
lbs);

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).

- A positive urine drug screen.

- Subjects who have attempted suicide in the past.

- Subjects who have an unexplained history of sudden death in their family

NCT02201511
Pfizer
Completed
A Healthy Volunteer Trial to Gain Information About the Blood Concentrations of PF-06412562 After Oral Administration of a Modified Release Formulation in Fasted and Fed Conditions

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Descriptive Information
Brief Title  ICMJE A Healthy Volunteer Trial to Gain Information About the Blood Concentrations of PF-06412562 After Oral Administration of a Modified Release Formulation in Fasted and Fed Conditions
Official Title  ICMJE A Phase 1, Open-label Study In Healthy Subjects To Investigate the Pharmacokinetics Of Pf-06412562 Following Single Oral Administration Of Modified Release Formulation In Fasted And Fed States
Brief Summary The study is designed to understand the blood concetration of PF-06412562 and its metabolite, PF-06663872, following a single oral dose of a modified release formulation. The study will include two doses of the PF-06412562 modified release formulation to understand the proportionality. Effect of food on absorption of PF-06412562 from the modified release formulation will also be investigated in this study.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: 3 mg PF-06412562 MR tablets_Fasted
    A single modified release tablet with 3 mg PF-06412562 administered after an overnight fast
  • Drug: 2 x 15 mg PF-06412562 MR tablets_Fasted
    Two 15 mg PF-06412562 modified release tablets administered after an overnight fast
  • Drug: 2 x 15 mg PF-06412562 MR tablets_Fed
    Two 15 mg PF-06412562 modified release tablets administered after a high fat breakfast
  • Drug: 10 mg PF-06412562 IR tablets
    a single immediate release tablet of 10 mg PF-06412562 after an overnight fast
Study Arms  ICMJE
  • Experimental: Arm 1
    Intervention: Drug: 3 mg PF-06412562 MR tablets_Fasted
  • Experimental: 2
    Intervention: Drug: 2 x 15 mg PF-06412562 MR tablets_Fasted
  • Experimental: 3
    Intervention: Drug: 2 x 15 mg PF-06412562 MR tablets_Fed
  • Experimental: 4
    Intervention: Drug: 10 mg PF-06412562 IR tablets
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: July 24, 2014) 		12
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2014
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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).
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs);

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).
  • A positive urine drug screen.
  • Subjects who have attempted suicide in the past.
  • Subjects who have an unexplained history of sudden death in their family
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (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 NCT02201511
Other Study ID Numbers  ICMJE B7441006
2014-001214-25 ( EudraCT Number )
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 November 2015

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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