Absolute Bioavailability of Baricitinib
Research type
Research Study
Full title
An Absolute Bioavailability Study of Baricitinib in Healthy Subjects Using the Intravenous Tracer Method
IRAS ID
166593
Contact name
Ashley Brooks
Contact email
Sponsor organisation
Lilly UK
Eudract number
2014-000819-13
Duration of Study in the UK
0 years, 1 months, 12 days
Research summary
Baricitinib is a new medication under development to treat people who suffer with rheumatoid arthritis (a type of joint disease), psoriasis (a skin condition with rash), and diabetic nephropathy (kidney disease due to diabetes).
Baricitinib has already been given to humans including patients who suffer with above mentioned conditions.
This is a single-site, open label (volunteers and staff involved in the study will know the type of medications used) study. Eight volunteers will be enrolled and dosed initially, in a single group, to ensure at least 6 subjects complete the study.
Subjects will be admitted to the clinical research unit (CRU) on Day -1 and will remain resident until after the Day 3 assessments have been completed. On Day 1, subjects will receive a single oral dose of 4 mg baricitinib, and at approximately the same time an intravenous (through the vein) administration of approximately 4 µg [13C] baricitinib will be started. The infusion (intravenous baricitinib) will run for approximately 1.5 hours.
The injected Study Drug will be labelled with [13C]. This means that a substance (Carbon 13) which is a naturally occurring alternative form of carbon and is not radioactive will be incorporated into the Study Drug to allow us to trace the 2 different administrations of Study Drugin the blood.
Subjects will return to the CRU on Day 4 for an outpatient visit for collection of a blood sample. A follow up visit will take place approximately 7 to 14 days after dosing.
REC name
North East - York Research Ethics Committee
REC reference
14/NE/1182
Date of REC Opinion
19 Nov 2014
REC opinion
Favourable Opinion