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A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of PF-06651600 in Subjects With Hepatic Impairment and Healthy Volunteers

Last updated on November 14, 2019

FOR MORE INFORMATION
Study Location
University of Miami Division of Clinical Pharmacology
Miami, Florida, 33136 United States
Contact
1-800-718-1021
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

- 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 40 kg/m2; and a total body weight >50 kg (110 lb)

Additional Inclusion Criteria for Participants with Normal Hepatic Function:

- Healthy male or female participants

- No known or suspected hepatic disease

Additional Inclusion Criteria for Participants with Impaired Hepatic Function:

- Stable hepatic impairment, defined as no clinically significant change in disease
status within the last 30 days prior to the Screening visit

- No other ongoing clinically significant abnormalities based on medical history,
physical examination, vital signs, 12-lead ECG, and clinical laboratory tests except
for the abnormal findings that are related to the participant's hepatic impairment.

- Satisfy the criteria for Class A or Class B of the Child-Pugh classification (mild:
Child-Pugh Scores 5-6 points, and moderate: Child Pugh Scores 7-9 points), within 28
days of investigational product administration.

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

- Has active acute or chronic infection requiring treatment or history of systemic
infection requiring hospitalization, incl. herpes zoster, herpes simplex, tuberculosis

- Infection with hepatitis B, hepatitis C or HIV

- Any condition affecting drug absorption, distribution, metabolism and excretion (eg,
status post porta-caval shunt surgery, prior bariatric surgery, gastrectomy, ileal
resection)

- Has malignancy, lymphoproliferative disorder, surgery or other condition not allowed
per protocol

Additional Exclusion Criteria for Participants with Normal Hepatic Function:

- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary,
gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, gynecologic or
allergic disease

Additional Exclusion Criteria for Participants with Impaired Hepatic Function:

- Has encephalopathy, severe ascites and/or pleural effusion, Child-Pugh score >9 or
medical conditions (like hepatorenal syndrome, gastrointestinal hemorrhage, etc.) excluded
per protocol

NCT04016077
Pfizer
Recruiting
A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of PF-06651600 in Subjects With Hepatic Impairment and Healthy Volunteers

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Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of PF-06651600 in Subjects With Hepatic Impairment and Healthy Volunteers
Official Title  ICMJE A PHASE 1, NON-RANDOMIZED, OPEN LABEL, MULTIPLE DOSE STUDY TO EVALUATE THE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF PF 06651600 IN SUBJECTS WITH HEPATIC IMPAIRMENT AND IN HEALTHY SUBJECTS WITH NORMAL HEPATIC FUNCTION
Brief SummaryThe purpose of this study is to characterize the effect of hepatic impairment on the pharmacokinetic(s) (PK) of PF-06651600 following administration of multiple once daily doses of PF-06651600. The safety and tolerability of PF-06651600 will also be evaluated in this study.
Detailed DescriptionNot 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-06651600 30 mg
PF-06651600 in 10 mg oral tablets will be administered on days 1 to 10.
Study Arms  ICMJE
  • Experimental: PF-06651600 Moderate Hepatic Impairment
    This arm includes participants with moderate hepatic impairment who will receive oral doses of PF-06651600 30 mg on Day 1 through Day 10.
    Intervention: Drug: PF-06651600 30 mg
  • Experimental: PF-06651600 Healthy participants
    This arm includes healthy adult participants who will receive oral doses of PF-06651600 30 mg on Day 1 through Day 10.
    Intervention: Drug: PF-06651600 30 mg
  • Experimental: PF-06651600 Mild Hepatic Impairment

    This arm is in Part 2 which will be conducted if the decision criterion to proceed to Part 2 is met.

    The arm includes participants with mild hepatic impairment who will receive oral doses of PF-06651600 30 mg on Day 1 through Day 10.

    Intervention: Drug: PF-06651600 30 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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 10, 2019)
24
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 1, 2020
Estimated Primary Completion DateOctober 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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 40 kg/m2; and a total body weight >50 kg (110 lb)

Additional Inclusion Criteria for Participants with Normal Hepatic Function:

  • Healthy male or female participants
  • No known or suspected hepatic disease

Additional Inclusion Criteria for Participants with Impaired Hepatic Function:

  • Stable hepatic impairment, defined as no clinically significant change in disease status within the last 30 days prior to the Screening visit
  • No other ongoing clinically significant abnormalities based on medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory tests except for the abnormal findings that are related to the participant's hepatic impairment.
  • Satisfy the criteria for Class A or Class B of the Child-Pugh classification (mild: Child-Pugh Scores 5-6 points, and moderate: Child Pugh Scores 7-9 points), within 28 days of investigational product administration.

Exclusion Criteria:

  • Has active acute or chronic infection requiring treatment or history of systemic infection requiring hospitalization, incl. herpes zoster, herpes simplex, tuberculosis
  • Infection with hepatitis B, hepatitis C or HIV
  • Any condition affecting drug absorption, distribution, metabolism and excretion (eg, status post porta-caval shunt surgery, prior bariatric surgery, gastrectomy, ileal resection)
  • Has malignancy, lymphoproliferative disorder, surgery or other condition not allowed per protocol

Additional Exclusion Criteria for Participants with Normal Hepatic Function:

- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, gynecologic or allergic disease

Additional Exclusion Criteria for Participants with Impaired Hepatic Function:

- Has encephalopathy, severe ascites and/or pleural effusion, Child-Pugh score >9 or medical conditions (like hepatorenal syndrome, gastrointestinal hemorrhage, etc.) excluded per protocol

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: Pfizer CT.gov Call Center1-800-718-1021[email protected]
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04016077
Other Study ID Numbers  ICMJE B7981016
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
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/da....
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateSeptember 2019

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]

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