Study of PF-05221304 in Subjects With Varying Degrees of Hepatic Impairment

NCT03309202

Last updated date
Study Location
Orlando Clinical Research Center
Orlando, Florida, 32809, United States
Contact
1-800-718-1021

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


All subjects -


- Adults <18 years of age and >70 years of age


- BMI < 17.5 and > 35.4 kg/m2


- HIV positive


- Conditions that affect drug absorption


- Positive breath alcohol test


Healthy/ those without hepatic impairment -


- Known or suspected hepatic impairment


- Evidence of Hepatitis B or C


- On any chronic medications


Those with varying degrees of hepatic impairment -


- Not meeting Classification A, B, or C of hepatic impairment based on Child-Pugh
Classification


- Evidence of Hepatic carcinoma or hepatorenal syndrome or limited predicted life
expectancy


- Recent GI bleed


- Moderate or severe renal impairment


- Hepatic encephalopathy Grade 3 or higher

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study of PF-05221304 in Subjects With Varying Degrees of Hepatic Impairment
Official Title  ICMJE A PHASE 1, NON-RANDOMIZED, OPEN-LABEL, SINGLE-DOSE, PARALLEL COHORT STUDY TO COMPARE THE PHARMACOKINETICS OF PF-05221304 IN ADULT SUBJECTS WITH VARYING DEGREES OF HEPATIC IMPAIRMENT RELATIVE TO SUBJECTS WITHOUT HEPATIC IMPAIRMENT
Brief Summary Hepatic impairment PK study
Detailed Description This is a non randomized, open label, single dose, parallel cohort, multisite study to investigate the effect of varying degrees of hepatic impairment on the plasma pharmacokinetics (total and unbound) of PF-05221304 after a single oral dose administered in the fed state.
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
Intervention  ICMJE Drug: PF-05221304
25 mg dose
Other Name: experimental drug
Study Arms  ICMJE
  • Experimental: Cohort 1_Without impairment
    Single, 25 mg dose of PF-05221304
    Intervention: Drug: PF-05221304
  • Experimental: Cohort 2_Mild impairment
    Single, 25 mg dose of PF-05221304
    Intervention: Drug: PF-05221304
  • Experimental: Cohort 3_Moderate impairment
    Single, 25 mg dose of PF-05221304
    Intervention: Drug: PF-05221304
  • Experimental: Cohort 4_Severe impairment
    Single, 25 mg dose of PF-05221304
    Intervention: Drug: PF-05221304
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: October 10, 2017)
24
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 18, 2018
Actual Primary Completion Date June 26, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Exclusion Criteria:

All subjects -

  • Adults <18 years of age and >70 years of age
  • BMI < 17.5 and > 35.4 kg/m2
  • HIV positive
  • Conditions that affect drug absorption
  • Positive breath alcohol test

Healthy/ those without hepatic impairment -

  • Known or suspected hepatic impairment
  • Evidence of Hepatitis B or C
  • On any chronic medications

Those with varying degrees of hepatic impairment -

  • Not meeting Classification A, B, or C of hepatic impairment based on Child-Pugh Classification
  • Evidence of Hepatic carcinoma or hepatorenal syndrome or limited predicted life expectancy
  • Recent GI bleed
  • Moderate or severe renal impairment
  • Hepatic encephalopathy Grade 3 or higher
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,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03309202
Other Study ID Numbers  ICMJE C1171006
2017-003034-86 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
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 June 2019

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