Effect of Omeprazole on Baricitinib PK in Healthy subjects
Research type
Research Study
Full title
Evaluation of the Impact of Increased Gastric pH following Omeprazole Administration on the Absorption of Baricitinib in Healthy Subjects
IRAS ID
134326
Contact name
Ashley Brooks
Contact email
Sponsor organisation
Eli Lilly and Company
Eudract number
2013-001859-12
ISRCTN Number
n/a
Clinicaltrials.gov Identifier
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.
Proton pump inhibitors such as omeprazole are the standard treatment for gastrointestinal ulcers and gastric reflux. Omeprazole inhibits gastric acid secretion and thereby makes the gastric environment less acidic and more alkaline, which may alter the absorption of some drugs with acid-base dependent solubility. The purpose of this study is to determine the effect of an alkaline gastric environment on exposure to a single dose of 10 mg baricitinib.
This is a single-site, open-label, 2-period, fixed-sequence study. Each subject will receive a single dose of baricitinib (10 mg) administered alone in Period 1. In Period 2, subjects will receive 40 mg omeprazole QD on Days 3 through 10, and a single dose of 40 mg omeprazole coadministered with 10 mg baricitinib on Day 10.
The length of study is approximately 12 days from the first dose of study drug in Period 1 to discharge from the CRU at the end of Period 2.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
13/SC/0372
Date of REC Opinion
18 Sep 2013
REC opinion
Further Information Favourable Opinion