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A Pharmacokinetic Study of Baricitinib in Participants With Liver Disease

Primary Purpose

Liver Diseases, Hepatic Insufficiency

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Baricitinib
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Liver Diseases

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria for ALL Participants:

  • 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

Additional Inclusion Criteria for Healthy Participants:

  • 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

Additional Inclusion Criteria for Hepatically Impaired Participants:

  • 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 for ALL Participants:

  • 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

Additional Exclusion Criteria for Healthy Participants:

  • 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
  • Intend to use over-the-counter or prescription medication and/or herbal supplements within 14 days prior to dosing and during the study

Additional Exclusion Criteria for Liver Impaired Participants:

  • Have creatinine clearance less than or equal to 50 milliliter per minute (mL/min) using the Cockcroft and Gault formula
  • Show evidence of spontaneous bacterial peritonitis within 6 month of dosing
  • Have had variceal bleeding within 3 months of check in
  • Show evidence of severe hyponatremia (sodium less than 120 millimolar per liter (mmol/L)
  • Have severe encephalopathy (Grade 3 to 4)
  • Have moderate to severe ascites (moderately hepatically impaired participants only)
  • Show presence of a portal shunt
  • Have hemoglobin less than 9.0 grams per deciliter (g/dL)
  • Have serum bilirubin greater than 15 milligrams per deciliter (mg/dL)

Sites / Locations

  • 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.
  • 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.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Baricitinib (Healthy)

Baricitinib (Moderate)

Baricitinib (Mild)

Arm Description

Group 1: 4 milligrams (mg) baricitinib administered once, orally, to participants with normal hepatic function.

Group 2: 4 mg baricitinib administered once, orally, to participants with moderate hepatic impairment.

Group 3: 4 mg baricitinib administered once, orally, to participants with mild hepatic impairment. Enrollment is contingent on data from Groups 1 and 2.

Outcomes

Primary Outcome Measures

Pharmacokinetics (PK): Maximum Concentration (Cmax) of Baricitinib (LY3009104)
PK: Area Under the Concentration Versus Time Curve From Zero to Infinity [AUC(0-∞)] of Baricitinib

Secondary Outcome Measures

Full Information

First Posted
June 3, 2013
Last Updated
May 15, 2017
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT01870388
Brief Title
A Pharmacokinetic Study of Baricitinib in Participants With Liver Disease
Official Title
A Pharmacokinetic Study of Baricitinib in Subjects With Hepatic Dysfunction
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Diseases, Hepatic Insufficiency

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Baricitinib (Healthy)
Arm Type
Experimental
Arm Description
Group 1: 4 milligrams (mg) baricitinib administered once, orally, to participants with normal hepatic function.
Arm Title
Baricitinib (Moderate)
Arm Type
Experimental
Arm Description
Group 2: 4 mg baricitinib administered once, orally, to participants with moderate hepatic impairment.
Arm Title
Baricitinib (Mild)
Arm Type
Experimental
Arm Description
Group 3: 4 mg baricitinib administered once, orally, to participants with mild hepatic impairment. Enrollment is contingent on data from Groups 1 and 2.
Intervention Type
Drug
Intervention Name(s)
Baricitinib
Other Intervention Name(s)
LY3009104
Intervention Description
Administered orally
Primary Outcome Measure Information:
Title
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Baricitinib (LY3009104)
Time Frame
Predose up to 48 hours (h) postdose
Title
PK: Area Under the Concentration Versus Time Curve From Zero to Infinity [AUC(0-∞)] of Baricitinib
Time Frame
Predose up to 48 h postdose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria for ALL Participants: 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 Additional Inclusion Criteria for Healthy Participants: 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 Additional Inclusion Criteria for Hepatically Impaired Participants: 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 for ALL Participants: 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 Additional Exclusion Criteria for Healthy Participants: 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 Intend to use over-the-counter or prescription medication and/or herbal supplements within 14 days prior to dosing and during the study Additional Exclusion Criteria for Liver Impaired Participants: Have creatinine clearance less than or equal to 50 milliliter per minute (mL/min) using the Cockcroft and Gault formula Show evidence of spontaneous bacterial peritonitis within 6 month of dosing Have had variceal bleeding within 3 months of check in Show evidence of severe hyponatremia (sodium less than 120 millimolar per liter (mmol/L) Have severe encephalopathy (Grade 3 to 4) Have moderate to severe ascites (moderately hepatically impaired participants only) Show presence of a portal shunt Have hemoglobin less than 9.0 grams per deciliter (g/dL) Have serum bilirubin greater than 15 milligrams per deciliter (mg/dL)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
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.
City
Miami
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
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.
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States

12. IPD Sharing Statement

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A Pharmacokinetic Study of Baricitinib in Participants With Liver Disease

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