Baricitinib and Ciclosporin Interaction Study
Research type
Research Study
Full title
A Study to Investigate the Effect of Ciclosporin on the Pharmacokinetics of Baricitinib (LY3009104) in Healthy Subjects
IRAS ID
137528
Contact name
Joseph Chiesa
Contact email
Sponsor organisation
Lilly UK
Eudract number
2013-002930-19
ISRCTN Number
N/A
Clinicaltrials.gov Identifier
N/A
Research summary
Baricitinib (LY3009104) is an investigational drug being developed as a treatment for inflammatory conditions including rheumatoid arthritis and psoriasis.
Inflammation is a normal response in the body to harmful stimuli such as physical damage to cells, irritant chemicals or infections. The symptoms involve heat, redness and swelling which help repair damage or remove harmful bacteria. The process works by chemicals being released from cells and signalling the body to initiate an inflammatory response. An abnormal or exaggerated inflammatory response can cause inflammatory diseases. Baricitinib works by regulating the chemicals responsible for the inflammatory response and may reduce unwanted inflammation.Ciclosporin is an immunosuppressant drug used to prevent rejection of transplanted organs. It interferes with the production of white blood cells which are involved in removing foreign objects (including infections or transplanted organs) from the body. Ciclosporin also blocks a protein called P glycoprotein which increases the excretion of toxins (including drugs) by the kidneys, thereby reducing their levels in the body. As ciclosporin blocks the action of P glycoprotein, and because the study drug (baricitinib) is predominantly removed by the kidney, the levels of baricitinib may be increased when the two drugs are taken together. This study will help to determine if the dose of the baricitinib needs to be altered when prescribed to patients taking ciclosporin or other drugs that block the action of P-glycoprotein.
This is a single site study involving up to 18 healthy subjects. Subjects will receive single doses of baricitinib on Days 1 and 4 and a single dose of ciclosporin on Day 4. The metabolisms of baricitinib on Days 1 and 4 will be compared to determine if there is any difference following ciclosporin dosing.
Subject participation is expected to last approximately 6 weeks from the time of screening until the Final follow-up visit.REC name
South Central - Berkshire B Research Ethics Committee
REC reference
13/SC/0431
Date of REC Opinion
3 Oct 2013
REC opinion
Further Information Favourable Opinion