KD025 Drug-Drug Interaction Study (QSC200311)
Research type
Research Study
Full title
A Four Period Sequential, Non-Randomised, Open Label Study to Evaluate the Effect of Itraconazole, Rifampicin and Rabeprazole on the Pharmacokinetics of KD025
IRAS ID
242012
Contact name
Sanjay Aggarwal
Contact email
Sponsor organisation
Kadmon Corporation, LLC
Eudract number
2018-000316-16
Duration of Study in the UK
0 years, 3 months, 20 days
Research summary
The Sponsor is developing the test medicine, KD025, as a potential treatment of a range of autoimmune disorders and fibrosis. Autoimmune disorders are conditions where the immune system mistakenly attacks the body. The immune system usually defends the body from disease and infection, but in the case of autoimmune disorders the immune system mistakes parts of the body as foreign, and attacks them. Fibrosis is a build up of scar tissue in an organ, such as the lungs, and is the cause of fibrotic diseases such as idiopathic pulmonary fibrosis.\n \nThe purpose of this study is to see how taking the other marketed medications, Itraconazole, Rifampicin and Rabeprazole affects how well the body takes up KD025.\n\nThe study will consist of 4 periods involving up to 40 healthy male volunteers. In each period, subjects will receive a single dose of 200 mg KD025, in the fed state (with food). In Period 1, subjects will receive KD025 alone. In periods 2 to 4, subjects will receive KD025 with Itraconazole, Rifampicin and Rabeprazole respectively. Once dosed with KD025, subjects will remain on-site for 3 days for blood samples to be taken and safety assessments performed. \n
REC name
South Central - Oxford A Research Ethics Committee
REC reference
18/SC/0117
Date of REC Opinion
3 Apr 2018
REC opinion
Further Information Favourable Opinion