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A Study To Evaluate Different Formulations Of PF-06865571 In Healthy Subjects

Last updated on October 10, 2019

FOR MORE INFORMATION
Study Location
Pfizer Clinical Research Unit
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
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Healthy males and female of non-childbearing potential

- Age of 18-55, inclusive

- Body Mass Index 17.5 to 30.5 kg/m2, inclusive

- Body weight >50 kg

- Not on any prescription or non-prescription drugs within 7 days or 5 half-lives prior
to first dose.

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, neurological, 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).

- A positive urine drug test.

- History of regular alcohol consumption exceeding 14 drinks/week for female subjects or
21 drinks/week for male subjects (1 drink = 5 ounces [150 mL] of wine or 12 ounces
[360 mL] of beer or 1.5 ounces [45 mL] of hard liquor) within 6 months before
screening.

- Treatment with an investigational drug within 30 days (or as determined by the local
requirement) or 5 half lives preceding the first dose of investigational product
(whichever is longer).

- Screening supine BP >=140 mm Hg (systolic) or >= 90 mm Hg (diastolic), following at
least 5 minutes of supine rest.

- Screening supine 12 lead ECG demonstrating a corrected QT (QTc) interval >450 msec or
a QRS interval >120 msec.

- Subjects with ANY of the following abnormalities in clinical laboratory tests at
screening, as assessed by the study specific laboratory and confirmed by a single
repeat test, if deemed necessary:

- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level >=1.25 ×
upper limit of normal (ULN);

- Total bilirubin level >=1.5 × ULN; subjects with a history of Gilbert's syndrome
may have direct bilirubin measured and would be eligible for this study provided
the direct bilirubin level is =

- Fertile male subjects who are unwilling or unable to use a highly effective method of
contraception as outlined in this protocol for the duration of the study and for at
least 28 days after the last dose of investigational product.

- Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more
within 60 days prior to dosing.

- History of sensitivity to heparin or heparin induced thrombocytopenia only if heparin
is used to flush any intravenous catheters in the study.

- History of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C; positive
testing for HIV, hepatitis B surface antigen (HepBsAg), hepatitis B core antibody
(HepBcAb), or hepatitis C antibody (HCVAb).

- Unwilling or unable to comply with Lifestyle Requirements in the protocol

- Subjects who are investigator site staff members directly involved in the conduct of
the study and their family members, site staff members otherwise supervised by the
investigator, or subjects who are Pfizer employees, including their family members,
directly involved in the conduct of the study.

- Other acute or chronic medical or psychiatric condition including recent (within the
past year) or active suicidal ideation or behavior or laboratory abnormality that may
increase the risk associated with study participation or investigational product
administration or may interfere with the interpretation of study results and, in the
judgment of the investigator, would make the subject inappropriate for entry into this
study.

- Subjects who have previously participated in prior studies with PF 06865571 as the
investigational product.

NCT03372044
Pfizer
Recruiting
A Study To Evaluate Different Formulations Of PF-06865571 In Healthy Subjects

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Descriptive Information
Brief Title  ICMJE A Study To Evaluate Different Formulations Of PF-06865571 In Healthy Subjects
Official Title  ICMJE A Phase 1, Open Label Study In Healthy Subjects To Investigate The Pharmacokinetics Of Pf 06865571 Following Single Oral Administration Of Immediate And Modified Release Tablets Compared To Immediate Release Oral Suspension Under Fed Conditions
Brief SummaryAn open-label study to understand the effect of different modified release and immediate release formulations on plasma PF-06865571 concentrations after single oral administration under fed conditions
Detailed DescriptionNot 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: PF-06865571 Immediate release suspension
    Suspension
  • Drug: PF-06865571 Slow release MR tablets
    Modified release tablets
  • Drug: PF-06865571 Fast release MR tablets
    Modified release tablets
  • Drug: PF-06865571 Immediate release tablets
    Immediate release tablets
Study Arms  ICMJE Experimental: PF-06865571
Treatment
Interventions:
  • Drug: PF-06865571 Immediate release suspension
  • Drug: PF-06865571 Slow release MR tablets
  • Drug: PF-06865571 Fast release MR tablets
  • Drug: PF-06865571 Immediate release 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: December 12, 2017)
12
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 4, 2018
Actual Primary Completion DateMarch 9, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy males and female of non-childbearing potential
  • Age of 18-55, inclusive
  • Body Mass Index 17.5 to 30.5 kg/m2, inclusive
  • Body weight >50 kg
  • Not on any prescription or non-prescription drugs within 7 days or 5 half-lives prior to first dose.

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, 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).
  • A positive urine drug test.
  • History of regular alcohol consumption exceeding 14 drinks/week for female subjects or 21 drinks/week for male subjects (1 drink = 5 ounces [150 mL] of wine or 12 ounces [360 mL] of beer or 1.5 ounces [45 mL] of hard liquor) within 6 months before screening.
  • Treatment with an investigational drug within 30 days (or as determined by the local requirement) or 5 half lives preceding the first dose of investigational product (whichever is longer).
  • Screening supine BP >=140 mm Hg (systolic) or >= 90 mm Hg (diastolic), following at least 5 minutes of supine rest.
  • Screening supine 12 lead ECG demonstrating a corrected QT (QTc) interval >450 msec or a QRS interval >120 msec.
  • Subjects with ANY of the following abnormalities in clinical laboratory tests at screening, as assessed by the study specific laboratory and confirmed by a single repeat test, if deemed necessary:

    • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level >=1.25 × upper limit of normal (ULN);
    • Total bilirubin level >=1.5 × ULN; subjects with a history of Gilbert's syndrome may have direct bilirubin measured and would be eligible for this study provided the direct bilirubin level is =
  • Fertile male subjects who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after the last dose of investigational product.
  • Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to dosing.
  • History of sensitivity to heparin or heparin induced thrombocytopenia only if heparin is used to flush any intravenous catheters in the study.
  • History of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HepBsAg), hepatitis B core antibody (HepBcAb), or hepatitis C antibody (HCVAb).
  • Unwilling or unable to comply with Lifestyle Requirements in the protocol
  • Subjects who are investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.
  • Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
  • Subjects who have previously participated in prior studies with PF 06865571 as the investigational product.
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 NCT03372044
Other Study ID Numbers  ICMJE C2541003
2017-003797-14 ( EudraCT Number )
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product:Yes
Studies a U.S. FDA-regulated Device Product:No
Product Manufactured in and Exported from the U.S.:Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Plan Description:Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/da...
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateApril 2018

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