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

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ClinicalTrials.gov Identifier: NCT04016077
Recruitment Status : Not yet recruiting
First Posted : July 11, 2019
Last Update Posted : July 11, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
The 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.

Condition or disease Intervention/treatment Phase
Hepatic Impairment Healthy Participants Drug: PF-06651600 30 mg Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: 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
Estimated Study Start Date : July 17, 2019
Estimated Primary Completion Date : July 3, 2020
Estimated Study Completion Date : July 3, 2020

Arm Intervention/treatment
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.
Drug: PF-06651600 30 mg
PF-06651600 in 10 mg oral tablets will be administered on days 1 to 10.

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.
Drug: PF-06651600 30 mg
PF-06651600 in 10 mg oral tablets will be administered on days 1 to 10.

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.

Drug: PF-06651600 30 mg
PF-06651600 in 10 mg oral tablets will be administered on days 1 to 10.




Primary Outcome Measures :
  1. Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-24)] [ Time Frame: Hour 0 on days 7, 8 and 9, and Hour 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 14, 24 hours on day 10 ]
    AUC (0-24)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-24)

  2. Maximum Observed Plasma Concentration (Cmax) [ Time Frame: Hour 0 on days 7, 8 and 9, and Hour 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 14, 24 hours on day 10 ]

Secondary Outcome Measures :
  1. Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) [ Time Frame: Baseline (Day 0) up to 28 days after last dose of study medication ]
  2. Number of adverse events leading to discontinuation [ Time Frame: Baseline (Day 0) up to 28 days after last dose of study medication ]
  3. Number of participants with clinically significant change in vital signs from Baseline [ Time Frame: Baseline (Day 0) up to 28 days after last dose of study medication ]
  4. Number of participants with clinically significant abnormalities in clinical laboratory values [ Time Frame: Baseline (Day 0) up to 28 days after last dose of study medication ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04016077


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
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United States, Florida
University of Miami Division of Clinical Pharmacology Not yet recruiting
Miami, Florida, United States, 33136
University of Miami Hospitals and Clinics Not yet recruiting
Miami, Florida, United States, 33136
Orlando Clinical Research Center Not yet recruiting
Orlando, Florida, United States, 32809
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT04016077     History of Changes
Other Study ID Numbers: B7981016
First Posted: July 11, 2019    Key Record Dates
Last Update Posted: July 11, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
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/data_requests.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pfizer:
PF-06651600
Pharmacokinetics
Hepatic impairment

Additional relevant MeSH terms:
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Liver Diseases
Digestive System Diseases