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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-19

Study Completion Date

2020-03-05

Brief Summary

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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.

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Detailed Description

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Conditions

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Hepatic Impairment Healthy Participants

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

PF-06651600 30 mg

Intervention Type DRUG

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

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.

Group Type EXPERIMENTAL

PF-06651600 30 mg

Intervention Type DRUG

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

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.

Group Type EXPERIMENTAL

PF-06651600 30 mg

Intervention Type DRUG

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

Interventions

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PF-06651600 30 mg

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

Intervention Type DRUG

Eligibility Criteria

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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)

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

* 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

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

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes