A Pharmacokinetic Study of Baricitinib in Participants With Liver Disease

Phase 1

Completed

• Conditions: Hepatic Insufficiency; Liver Diseases
• Interventions: Drug: Baricitinib

• Registration Number: NCT01870388
• Lead Sponsor: Eli Lilly and Company

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-06-03
• Study First Submitted QC: 2013-06-03
• Study First Posted: 2013-06-06
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Results First Submitted: 2017-03-10
• Results First Submitted QC: 2017-03-10
• Results First Posted: 2017-04-21
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-15
• Last Update Posted: 2017-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Baricitinib (Moderate)	Baricitinib	Group 2: 4 mg baricitinib administered once, orally, to participants with moderate hepatic impairment.
Baricitinib (Mild)	Baricitinib	Group 3: 4 mg baricitinib administered once, orally, to participants with mild hepatic impairment. Enrollment is contingent on data from Groups 1 and 2.
Baricitinib (Healthy)	Baricitinib	Group 1: 4 milligrams (mg) baricitinib administered once, orally, to participants with normal hepatic function.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

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, United States