Baricitinib and Keto/Flu DDI
Research type
Research Study
Full title
The Effect of Ketoconazole or Fluconazole on the Pharmacokinetics of Baricitinib in Healthy Subjects
IRAS ID
134358
Contact name
Jim Bush
Contact email
Sponsor organisation
Eli Lilly and Company Limited
Eudract number
2013-002105-57
ISRCTN Number
N/A
Research summary
Baricitinib is an investigational drug being developed as a treatment for inflammatory conditions such as rheumatoid arthritis and psoriasis.
Inflammation is the body’s normal response to harmful stimuli such as physical damage, irritant chemicals or infections. The symptoms help repair damage or remove harmful bacteria. The process works by chemicals that signal the body to initiate and maintain an inflammatory response (inflammatory cytokines). Abnormal or exaggerated inflammatory response can lead to the development of inflammatory diseases. Baricitinib works by regulating inflammatory cytokines to reduce unwanted inflammation.
Ketoconazole and fluconazole are licensed drugs used to treat fungal infections. Repeated dosing with ketoconazole or fluconazole causes decreased activity of an enzyme family called CYP3A. The CYP3A enzymes are involved in breaking down many drugs, including baricitinib. This study will assess if ketoconazole or fluconazole dosing affect 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 these or other drugs that decrease activity of CYP3A enzymes.
This is a single site, 2-period study involving up to 36 healthy subjects. All subjects will receive single doses of baricitinib (10mg) on Day 1.
Half of the subjects will receive ketoconazole (400mg) daily between days 3 and 8 and a further dose of baricitinib (10mg) on Day 6.
The other subjects will receive fluconazole daily between days 3 and 9 (400mg on Day 3, 200 mg on Days 4 – 9) and a further dose of baricitinib (10mg) on Day 7.
The metabolisms of baricitinib on Days 1 and 6 or 7 will be compared to determine if there is any difference following repeated ketoconazole or fluconazole dosing respectively.Subject participation is expected to last approximately 7 weeks from the time of screening until the Final follow-up visit.
REC name
North East - York Research Ethics Committee
REC reference
13/NE/0200
Date of REC Opinion
18 Jul 2013
REC opinion
Favourable Opinion