Baricitinib and OC DDI
Research type
Research Study
Full title
The Effects of Multiple Doses of Baricitinib on the Pharmacokinetics of a Single Dose of an Oral Contraceptive in Healthy Female Subjects
IRAS ID
130551
Contact name
Ashley Brooks
Contact email
Sponsor organisation
Eli Lilly and Company Limited
Eudract number
2013-001441-14
ISRCTN Number
N/A
Research summary
Baricitinib (formerly identified as INCB028050 and 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 process works by chemicals being released from cells and signalling the body to start an inflammatory response. If the body’s inflammatory response is abnormal or exaggerated, this can lead to the development of various inflammatory diseases. Baricitinib (LY3009104) works by regulating the chemicals which are responsible for the abnormal inflammatory response and therefore has the potential to reduce the unwanted inflammation.
This is an open-label, fixed-sequence, 2 period study. It is intended that up to 20 female subjects may be enrolled so that at least 14 subjects complete the study.
Subjects will receive each of the following treatments:
• Treatment Period 1: single dose of Microgynon
• Treatment Period 2: multiple doses of 10 mg baricitinib once a day for a total of 8 days. On the 7th day baricitinib will be coadministered with Microgynon.
Dosing occasions of Microgynon in Treatment Periods 1 and 2 will be separated by 28 days ± 1 day, and therefore Treatment Period 2 can commence on Day 23 ± 1 day. For a 27 day separation period between Microgynon dosing occasions, Treatment Period 2 will commence on Day 22. For a 29-day separation period between Microgynon dosing occasions, Treatment Period 2 will commence on Day 24.Screening will occur up to 30 days prior to the first dose of Microgynon on Day 1.
REC name
North East - York Research Ethics Committee
REC reference
13/NE/0174
Date of REC Opinion
20 Jun 2013
REC opinion
Favourable Opinion