Simvastatin drug-drug interaction study
Research type
Research Study
Full title
Effects of multiple Baricitinib (LY3009104) doses on the pharmacokinetics of a cytochrome P450 3A Substrate, simvastatin in healthy subjects
IRAS ID
137150
Contact name
Joseph Chiesa
Contact email
Sponsor organisation
Eli Lilly and Company Limited
Eudract number
2013-002917-36
ISRCTN Number
N/A
Clinicaltrials.gov Identifier
N/A
Research summary
Baricitinib (LY3009104) is being developed for the treatment of inflammatory diseases including rheumatoid arthritis, psoriasis, and diabetic nephropathy.
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.
This study is a drug interaction study, where we’ll be assessing the effect of baricitinib on the pharmacokinetic properties (blood drug levels and rate of removal) of simvastatin when administered together. Simvastatin is a licensed drug which is used to treat high levels of cholesterol (fat) in the blood, and is metabolised (broken down) in the body by a specific enzyme (CYP3A). Therefore, if baricitinib has any effect on the simvastatin, then the same effect can be assumed to happen when co-administering other drugs that are metabolised by the same enzyme (CYP3A).
This is a single site study involving up to 40 healthy subjects. During this study, subjects will be receiving 2 single separate doses of simvastatin on Day 1 and Day 6 in addition to dosing with baricitinib from Day 3 to Day 7. Subject participation is expected to last up to 6 weeks from the time of screening till the last post-study visit.REC name
South Central - Berkshire B Research Ethics Committee
REC reference
13/SC/0432
Date of REC Opinion
3 Oct 2013
REC opinion
Further Information Favourable Opinion