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Completed

A Hepatic Impairment Study for PF-04965842.

ClinicalTrials.gov ID NCT03626415
Sponsor Pfizer
Information provided by Pfizer (Responsible Party)
Last Update Posted 2020-05-18
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Study Overview

Brief Summary
This is a Phase 1 non randomized, open label, single dose, parallel cohort study to investigate the effect of hepatic impairment on the PK, safety and tolerability of PF 04965842.
Detailed Description
A minimum of 24 subjects with normal, mild or moderate hepatic function will be enrolled into the study, with approximately 8 subjects in each cohort. The Child Pugh classification score will be utilized to assess entry criteria and to assign subjects into the appropriate hepatic impairment group. For individual subjects, the total maximum duration of study participation from the Screening visit to the end of clinical research unit (CRU) stay is approximately 31 days and approximately 63 days from the Screening visit to the Follow up contact.
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Official Title
A PHASE 1, NON-RANDOMIZED, OPEN-LABEL, SINGLE-DOSE STUDY TO COMPARE THE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF PF-04965842 IN ADULT SUBJECTS WITH MILD AND MODERATE HEPATIC IMPAIRMENT RELATIVE TO SUBJECTS WITH NORMAL HEPATIC FUNCTION
Conditions
Hepatic Impairment
Intervention / Treatment
  • Drug: PF-04965842
  • Drug: PF-04965842
Other Study ID Numbers
  • B7451020
Study Start (Actual)
2018-10-01
Primary Completion (Actual)
2019-04-30
Study Completion (Actual)
2019-04-30
Enrollment (Actual)
24
Study Type
Interventional
Phase
Phase 1

Contacts and Locations

This section provides contact details for people who can answer questions about joining this study, and information on where this study is taking place.

To learn more, please see the Contacts and Locations section in How to Read a Study Record(https://clinicaltrials.gov/study-basics/how-to-read-study-record#contacts-and-locations).

Click to view interactive map

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies(https://clinicaltrials.gov/study-basics/learn-about-studies).
Eligibility Criteria
Description

Inclusion Criteria:

  • Body mass index (BMI) of 17.5 to 40 kg/m2; and a total body weight >50 kg (110 pounds).
  • Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.

Additional Inclusion Criteria for subjects with hepatic impairment:

  • Satisfy the criteria for Class A or Class B of the Child Pugh classification (mild: Child Pugh Scores 5 to 6 points, and moderate: Child Pugh Scores 7 to 9 points), within 14 days of investigational product administration.
  • A diagnosis of hepatic dysfunction due to hepatocellular disease (and not secondary to any acute ongoing hepatocellular process) documented by medical history, physical examination, liver biopsy, hepatic ultrasound, computerized tomography scan, or magnetic resonance imaging (MRI).

Exclusion Criteria:

  • Subjects with clinically significant infections within the past 3 months (for example, those requiring hospitalization, or as judged by the Investigator), evidence of any infection (including influenza) within the past 7 days, history of disseminated herpes simplex infection or recurrent (>1 episode) or disseminated herpes zoster.
  • Subjects with a malignancy or with a history of malignancy, with the exception of adequately treated or excised non metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ.

Additional exclusion criteria for subjects with hepatic impairment:

  • Hepatic carcinoma or hepatorenal syndrome or limited predicted life expectancy (defined as less than 1 year).
  • Subjects who have previously had a transplanted kidney, liver, or heart.
  • At Screening, persistent severe, uncontrolled hypertension.
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Ages Eligible for Study
18 Years to 70 Years (AdultOlder Adult )
Sexes Eligible for Study
All
Accepts Healthy Volunteers
Yes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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Design Details
Primary Purpose : Basic Science
Interventional Model : Parallel Assignment
Interventional Model Description: Recruitment for subjects with moderate and mild hepatic impairment (Cohorts 1 and 2) will initiate first and these subjects will be enrolled in parallel.
Masking : None (Open Label)

Arms and Interventions

Participant Group/Arm Intervention/Treatment
Participant Group/Arm Experimental: PF-04965842
PF 04965842 is an orally bioavailable small molecule that selectively inhibits JAK1.
Intervention/Treatment Drug: PF-04965842
  • PF 04965842 is an orally bioavailable small molecule that selectively inhibits JAK1.

Primary Outcome Measures
Outcome Measure Measure Description Time Frame
Maximum Observed Plasma Concentration (Cmax) for PF-04965842Cmax is maximum plasma concentration. It was observed directly from data.0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 14, 24, 36, 48, 72 hours post-dose in each cohort
Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUCinf) for PF-04965842AUCinf is area under the concentration-time curve (AUC) from time 0 (pre-dose) extrapolated to infinite time.0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 14, 24, 36, 48, 72 hours post-dose in each cohort
Secondary Outcome Measures
Outcome Measure Measure Description Time Frame
Number of Participants With Treatment-Emergent Adverse Events (AEs) for PF-04965842Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent adverse events (TEAEs) were those with initial onset or increasing in severity between the first dose of investigational product and up to 36 days post-dose.From screening (within 28 days prior to Day 1) till up to 36 days post-dose, the total maximum duration was approximately 63 days for individual participants.
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)Laboratory tests included tests that were performed under the categories of hematology, chemistry, urinalysis, other, and additional tests needed for Hy's law.Screening (within 28 days prior to Day 1), Day -1, 2, 24, 72 hours post-dose.
Number of Participants With Electrocardiogram (ECG) Findings of Potential Clinical Importance for PF-0496584212-Lead ECGs were collected after the participants rested quietly for at least 10 minutes in a supine position. Clinical significance of ECG recordings was determined at the investigator's discretion.Screening (within 28 days prior to Day 1), Day -1, 2, 72 hours post-dose.
Number of Participants With Vital Sign Findings of Potential Clinical Importance for PF-04965842Vital signs (pulse rate, systolic and diastolic blood pressure) were obtained with participant following at least 5 minutes of supine rest. Clinical significance of vital signs was determined at the investigator's discretion.Screening (within 28 days prior to Day 1), 0 (pre-dose), and 72 hours post-dose.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.
Sponsor
Pfizer
Investigators
  • Study Director:Pfizer CT.gov Call Center,Pfizer

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
2018-08-08
First Submitted that Met QC Criteria
2018-08-08
First Posted
2018-08-13
Results Reporting Dates
Results First Submitted
2020-04-28
Results First Submitted that Met QC Criteria
2020-04-28
Results First Posted
2020-05-18
Study Record Updates
Last Update Submitted that met QC Criteria
2020-04-28
Last Update Posted
2020-05-18
Last Verified
2020-04

More Information

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Additional Relevant MeSH Terms

Plan to Share Individual Participant Data (IPD)?
No
IPD 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.