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A Pharmacokinetic Study of Baricitinib in Participants With Liver Disease | Clinical Trials | Clareo Health

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A Pharmacokinetic Study of Baricitinib in Participants With Liver Disease

A Pharmacokinetic Study of Baricitinib in Subjects With Hepatic Dysfunction

NCT01870388•Eli Lilly and Company

Summary

The main purpose of this study is to measure how much of the study drug called baricitinib gets into the blood stream and how long it takes the body to get rid of it. Healthy participants and those with liver disease may enroll. The study will last about 7 days for each participant, not including screening.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Male participants agree to use 2 reliable methods of birth control with female partners of child-bearing potential during the study and for at least 3 months following the last dose of study drug
•Women not of child-bearing potential due to surgical sterilization (at least 6 weeks after surgical bilateral oophorectomy with or without hysterectomy or at least 6 weeks after confirmed tubal occlusion/tubal ligation) confirmed by medical history or menopause
•Menopausal women with spontaneous amenorrhea for at least 12 months, not induced by a medical condition and by medications and have a follicle-stimulating hormone (FSH) level greater than 40 milli-international units per milliliter (mIU/mL) (unless the participant is taking hormone replacement therapy \[HRT\])
•Have a body mass index of 18.5 to 40.0 kilograms per square meter (kg/m\^2) inclusive at the time of screening
•Are overtly healthy participants, have normal hepatic function and have stable chronic medical conditions
•Have clinical laboratory test results within normal reference range for the population or investigator site, or results with acceptable deviations that are judged to be not clinically significant by the investigator
•Participants with hepatic impairment classified as Child-Pugh score A or B (mild \[Group 3, if enrolled\] or moderate \[Group 2\] impairment, respectively). Must have a diagnosis of chronic hepatic impairment (greater than 6 months), with no clinically significant changes within 90 days prior to study drug administration (Day 1). Participants may have mild stable baseline medical conditions for which neither the condition nor treatments received would negatively impact the health of the participant or study conduct
•Clinical laboratory test results with deviations that are judged by the investigator to be compatible with the hepatic impairment of the participant, or of no additional clinical significance for this study

Exclusion Criteria

•Have received, within the last 30 days, an investigational product as part of a clinical trial, or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
•Persons who have previously completed or withdrawn from study investigating baricitinib, and have previously received the investigational product
•Women with a positive pregnancy test or who are lactating
•Have a current or recent history (less than 30 days prior to screening and/or less than 45 days prior to admission to the clinical research unit) of a clinically significant bacterial, fungal, parasitic, viral (excluding rhinopharyngitis), or mycobacterial infection
•Have had symptomatic herpes zoster or herpes simplex infection within 90 days prior to the first dose
•Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies
•Have been exposed to a live vaccine within 12 weeks prior to the first dose or expected to need/receive a live vaccine (including herpes zoster vaccination) during the course of the study
•Show evidence of acute or chronic liver disease
•Show evidence of hepatitis B and/or positive hepatitis B and/or positive hepatitis B surface antigen
•Show evidence of hepatitis C and/or positive hepatitis C antibody
+10 more criteria

Locations (2)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Miami, Florida, United States

Orlando, Florida, United States

Key Dates

Start Date

June 1, 2013

Primary Completion Date

July 1, 2013

Completion Date

July 1, 2013

Last Updated

June 6, 2017

Enrollment

ACTUAL participants

Conditions

Liver DiseasesHepatic Insufficiency

Interventions

Baricitinib

DRUG

Diagnosis of Lymphohistiocytic Hemophagocytosis in Intensive Care

NCT07343037

Hepatic InsufficiencyCirrhosis, Liver

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RECRUITING

MAsS Scan as a Predictor of Morbidity and Mortality in Patients With Liver Disease

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RECRUITINGNA

Alcohol Misuse Treatment to Patients Newly Diagnosed With Alcohol-related Liver Disease: a Randomized Controlled Trial

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 6, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Pharmacokinetic Study of Baricitinib in Participants With Liver Disease

Inclusion Criteria

Exclusion Criteria

Diagnosis of Lymphohistiocytic Hemophagocytosis in Intensive Care

MAsS Scan as a Predictor of Morbidity and Mortality in Patients With Liver Disease

Alcohol Misuse Treatment to Patients Newly Diagnosed With Alcohol-related Liver Disease: a Randomized Controlled Trial

The Treatment of Liver Injury After Liver Resection With Polyene Phosphatidylcholine

Prevention of Post-TIPS Hepatic Encephalopathy by Administration of Rifaximin and Lactulose

Design and Implementation of the Pediatric Liver Transplantation Biobank