Baricitinib and Rifampicin DDI
Research type
Research Study
Full title
Protocol I4V-MC-JAGK The Effect of CYP3A Induction by Rifampicin on the Pharmacokinetics of Baricitinib in Healthy Subjects
IRAS ID
132042
Contact name
Jim Bush
Contact email
Sponsor organisation
Eli Lilly and COmpany Limited
Eudract number
2013-001704-11
ISRCTN Number
N/A
Research summary
Baricitinib (LY3009104) is an investigational drug which is being developed as a potential treatment for various inflammatory conditions such as 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 to 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. If the body’s inflammatory response is abnormal or exaggerated this can lead to the development of various inflammatory diseases. Baricitinib works by regulating the chemicals which are responsible for the abnormal inflammatory response and therefore has the potential to reduce the unwanted inflammation.
Rifampicin is a licensed drug which is used to prevent bacterial infections. Repeated dosing with rifampicin causes increased activity of an enzyme family called CYP3A in the liver. The CYP3A enzymes are involved in breaking down many drugs, including baricitinib. This study will assess if repeated rifampicin dosing affects the metabolism of baricitinib (how it is broken down by the body). This study will help determine if dosage adjustments are necessary when giving baricitinib to patients taking rifampicin or other drugs causing increased activity of CYP3A enzymes.
This is a single site study involving up to 18 healthy subjects. During this study subjects will receive single doses of baricitinib on Days 1 and 10 and rifampicin daily from Days 3 to 11. The metabolism of baricitinib on Days 1 and 10 will be compared to determine if there is any difference following repeated rifampicin dosing.
Subject participation is expected to last approximately 8 weeks from the time of screening until the Final follow-up visit.
REC name
North East - York Research Ethics Committee
REC reference
13/NE/0175
Date of REC Opinion
20 Jun 2013
REC opinion
Favourable Opinion