A STUDY TO COMPARE THE PHARMACOKINETICS OF PF-06835919 IN PARTICIPANTS WITH AND WITHOUT HEPATIC IMPAIRMENT

NCT04193436

Last updated date
Study Location
Pharmaceutical Research Associates CZ, s.r.o.
Praha 7, , 170 00, Czechia
Contact
1-800-718-1021

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

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1-800-718-1021

By email

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hepatic Impairment, Healthy Participants
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-70 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Male and female participants between the ages of 18 (or the minimum country specific age of consent if >18) and 70 years, inclusive, at the Screening visit:

- Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.

- Body mass index (BMI) of 17.5 to 35.4 kg/m2; and a total body weight >50 kg (110 lb).

- Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent document (ICD) and in this protocol.

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


- Any condition possibly affecting drug absorption (eg, prior bariatric surgery,
gastrectomy, ileal resection).


(Participants who have undergone cholecystectomy and/or appendectomy are eligible for this
study as long as the surgery occurred more than 6 months prior to Screening)..


- At Screening, participants with a positive result for human immunodeficiency virus
(HIV) antibodies, as assessed by sponsor identified central laboratory, with a single
repeat permitted to assess eligibility, if needed.


- Other acute or chronic medical or psychiatric condition including recent (within the
past year) or active suicidal ideation or behaviour 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 participant inappropriate for entry into
this study.


- Use of prior/concomitant therapies.


- Previous administration 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 used in this study (whichever is longer).


- Participants with known prior participation (ie, randomized and received at least 1
dose of investigational product) in a study involving PF 06835919.


- A positive urine drug test, for illicit drugs, and/or a positive breath alcohol test
at Screening. However, participants who have been medially prescribed opiates/opiods
or benzodiazepines and report the use of these drugs to the investigator at the
screening visit will be allowed to participate.


- Male participants with partners who are currently pregnant.


- Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more
within 60 days prior to dosing and until the follow-up contact.


- History of sensitivity to heparin or heparin induced thrombocytopenia, only if heparin
is used to flush intravenous catheters used during serial blood collections.


- Unwilling or unable to comply with the criteria in the Lifestyle Considerations
section of the protocol.


- 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
Pfizer employees, including their family members, directly involved in the conduct of
the study.

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

Pfizer Clinical Trials Contact Center

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[email protected]

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Advanced Information
Descriptive Information
Brief Title  ICMJE A STUDY TO COMPARE THE PHARMACOKINETICS OF PF-06835919 IN PARTICIPANTS WITH AND WITHOUT HEPATIC IMPAIRMENT
Official Title  ICMJE A PHASE 1, NON-RANDOMIZED, OPEN-LABEL, SINGLE-DOSE, PARALLEL COHORT STUDY TO COMPARE THE PHARMACOKINETICS OF PF-06835919 IN ADULT PARTICIPANTS WITH VARYING DEGREES OF HEPATIC IMPAIRMENT RELATIVE TO PARTICIPANTS WITHOUT HEPATIC IMPAIRMENT
Brief Summary The study is proposed to characterize the effect of varying degrees of hepatic impairment on the plasma PK of PF-06835919
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE
  • Hepatic Impairment
  • Healthy Participants
Intervention  ICMJE Drug: PF-06835919 25 mg
PF-06835919 in 25 mg oral tablet will be administered on Day 1
Study Arms  ICMJE
  • Experimental: PF-06835919 with severe hepatic impairement
    This arm includes participants with severe hepatic impairment who will receive a 25mg oral dose of PF-06835919
    Intervention: Drug: PF-06835919 25 mg
  • Experimental: PF-06835919 with moderate hepatic impairement
    This arm includes participants with moderate hepatic impairment who will receive a 25mg oral dose of PF-06835919
    Intervention: Drug: PF-06835919 25 mg
  • Experimental: PF-06835919 with mild hepatic impairement
    This arm includes participants with mild hepatic impairment who will receive a 25mg oral dose of PF-06835919
    Intervention: Drug: PF-06835919 25 mg
  • Experimental: PF-06835919 without hepatic impairment
    This arm includes participants without hepatic impairment who will receive a 25mg oral dose of PF-06835919
    Intervention: Drug: PF-06835919 25 mg
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 Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: December 6, 2019)
24
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 21, 2021
Estimated Primary Completion Date March 21, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male and female participants between the ages of 18 (or the minimum country specific age of consent if >18) and 70 years, inclusive, at the Screening visit:
  • Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
  • Body mass index (BMI) of 17.5 to 35.4 kg/m2; and a total body weight >50 kg (110 lb).
  • Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent document (ICD) and in this protocol.

Exclusion Criteria:

  • Any condition possibly affecting drug absorption (eg, prior bariatric surgery, gastrectomy, ileal resection).

(Participants who have undergone cholecystectomy and/or appendectomy are eligible for this study as long as the surgery occurred more than 6 months prior to Screening)..

  • At Screening, participants with a positive result for human immunodeficiency virus (HIV) antibodies, as assessed by sponsor identified central laboratory, with a single repeat permitted to assess eligibility, if needed.
  • Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behaviour 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 participant inappropriate for entry into this study.
  • Use of prior/concomitant therapies.
  • Previous administration 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 used in this study (whichever is longer).
  • Participants with known prior participation (ie, randomized and received at least 1 dose of investigational product) in a study involving PF 06835919.
  • A positive urine drug test, for illicit drugs, and/or a positive breath alcohol test at Screening. However, participants who have been medially prescribed opiates/opiods or benzodiazepines and report the use of these drugs to the investigator at the screening visit will be allowed to participate.
  • Male participants with partners who are currently pregnant.
  • Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to dosing and until the follow-up contact.
  • History of sensitivity to heparin or heparin induced thrombocytopenia, only if heparin is used to flush intravenous catheters used during serial blood collections.
  • Unwilling or unable to comply with the criteria in the Lifestyle Considerations section of the protocol.
  • 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 Pfizer employees, including their family members, directly involved in the conduct of the study.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 70 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,   Czechia,   Slovakia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04193436
Other Study ID Numbers  ICMJE C1061013
HEPATIC IMPAIRMENT ( Other Identifier: Alias Study Number )
2019-003480-21 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP