Clinical trial NCT04016077: A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of PF-06651600 in Subjects With Hepatic Impairment and Healthy Volunteers
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatic Impairment
Healthy Participants
Keywords: PF-06651600
Pharmacokinetics
Hepatic impairment
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2019-07-11
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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

Primary outcomes:
measure: Area Under the Plasma Concentration-time Profile From Time 0 to 24 Hours (AUC24) for PF-06651600
timeFrame: Hour 0 (pre-dose) on Days 7, 8 and 9, and hour 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 14, 24 hours post-dose on Day 10
measure: Maximum Plasma Concentration (Cmax) for PF-06651600
timeFrame: Hour 0 (pre-dose) on Days 7, 8 and 9, and hour 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 14, 24 hours post-dose on Day 10
Secondary outcomes:
measure: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) (All Causalities and Treatment-related)
timeFrame: Baseline (Day 0) up to 28 days after last dose of study medication (Day 39)
measure: Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality)
timeFrame: Baseline (Day 0) up to 28 days after last dose of study medication (Day 39)
measure: Number of Participants With Out of Range Vital Signs
timeFrame: Baseline (Day 0) up to 28 days after last dose of study medication (Day 39)
measure: Number of Adverse Events Leading to Discontinuation
timeFrame: Baseline (Day 0) up to 28 days after last dose of study medication (Day 39)
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami Division of Clinical Pharmacology
state: Florida
city: Orlando
country: United States
facility: Orlando Clinical Research Center
state: Florida
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: