A Pharmacokinetic Study of Baricitinib in Participants With Liver Disease

Part of paid clinical trials in Miami, Florida.

Sponsor
Eli Lilly and Company
Study ID
NCT01870388
Phase
PHASE1
Status
Completed

Conditions

  • Hepatic Insufficiency
  • Liver Diseases

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

Study Details

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.

Key Dates

Start date
Jun 30, 2013
Status verified
May 2017
Primary completion
Jul 31, 2013
Completion
Jul 31, 2013

Study Design

Enrollment
16 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

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

Primary Outcome Measure

Pharmacokinetics (PK): Maximum Concentration (Cmax) of Baricitinib (LY3009104) [ Time Frame: Predose up to 48 hours (h) postdose ]

Locations (2)

FacilityCityStateZIPSite coordinators
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.MiamiFlorida33014-
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.OrlandoFlorida32806-

Find similar trials in Miami, FL

By research site
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, FLFor 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, FL

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