A Study to Measure Baricitinib (LY3009104) Absorption in Healthy Participants

Sponsor
Eli Lilly and Company
Study ID
NCT02340104
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Volunteers

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

Study Details

The purpose of this study is to compare how much baricitinib (study drug) gets into the blood stream when it is given as a single dose (in tablet form) and as an intravenous infusion (injection given directly into a vein via a small needle). Each participant in the study will make four visits to the investigator site over the course of about 6 weeks.

Key Dates

Start date
Jan 31, 2015
Status verified
May 2017
Primary completion
Feb 28, 2015
Completion
Feb 28, 2015

Study Design

Enrollment
8 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Baricitinib
    Single oral dose of baricitinib and single intravenous (IV) infusion of \[\^13C4D3\^15N\]-baricitinib over 1.5 hours.

Primary Outcome Measure

Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Baricitinib Following Both the Oral and the IV Dose [ Time Frame: Predose, 0.5, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 Hours Postdose ]

Related Studies