A Pharmacokinetic Study of Baricitinib in Participants With Liver Disease

NCT01870388 | Completed Phase 1 Results

• 2 other identifiers: 14600I4V-MC-JAGC
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 2

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.

Conditions

Liver Diseases; Hepatic Insufficiency

Outcome Measures

Primary Outcomes (2)

• Pharmacokinetics (PK): Maximum Concentration (Cmax) of Baricitinib (LY3009104)

  Predose up to 48 hours (h) postdose

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

  Predose up to 48 h postdose

Study Arms (3)

Baricitinib (Healthy)

EXPERIMENTAL

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

Drug: Baricitinib

Baricitinib (Moderate)

EXPERIMENTAL

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

Drug: Baricitinib

Baricitinib (Mild)

EXPERIMENTAL

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

Drug: Baricitinib

Interventions

Baricitinib DRUG

Administered orally

Also known as: LY3009104

Baricitinib (Healthy); Baricitinib (Mild); Baricitinib (Moderate)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (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, 33014, United States

Location

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.

Orlando, Florida, 32806, United States

Location

MeSH Terms

Conditions

Liver Diseases; Hepatic Insufficiency

Interventions

baricitinib

Condition Hierarchy (Ancestors)

Digestive System Diseases

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

800-545-5979

Study Officials

• 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)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2013
• First Posted: June 6, 2013
• Study Start: June 1, 2013
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: June 6, 2017
• Results First Posted: April 21, 2017

Record last verified: 2017-05

Locations

US (2)