Bioavailability and ADME Study of KD025 in Healthy Males (QSC200323)
Research type
Research Study
Full title
An open-label, two-part study designed to assess the absolute bioavailability of KD025 and to determine the mass balance recovery, metabolite profile and identification of metabolite structures for [14C]-KD025 in healthy male subjects
IRAS ID
258663
Contact name
Olivier Schueller
Contact email
Sponsor organisation
Kadmon Corporation, LLC
Eudract number
2018-004773-28
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 1 months, 3 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. Fibrosis is the build-up of scar tissue in an organ which can be caused by autoimmune disorders.
The study will try to identify the absolute bioavailability of KD025 i.e. how much of the test medicine is taken up by the body when dosed once by mouth compared to when dosed once by injection directly into the vein. The study will also identify how the medicine is taken up, absorbed, processed and removed by the body when dosed once by mouth.
The study will consist of 2 parts. In Part 1, up to 6 healthy male subjects will receive an oral dose of KD025 following an overnight fast and a standard breakfast 30 min before dosing. The oral dose will be followed by an intravenous dose of radiolabelled [14C]-KD025. Blood will be collected for up to 48 hours after dosing for determination of the concentration of KD025 in the circulation from the oral dose, in comparison to the amount of [14C]-KD025 from intravenous infusion. Subjects will be resident in the clinic during this time and will be discharged after all blood samples have been collected.
In Part 2, the same subjects will receive a single oral dose of [14C]-KD025. Blood, urine and faecal samples will then be collected at regular intervals from each volunteer who will be resident in the clinical unit for approximately 8 days. The radiolabelled test medicine, which has a radioactive component will help us track where the medicine is in the body.
There will be a minimum of 7 days between Discharge from Part 1 and Admission to Part 2.
REC name
Wales REC 2
REC reference
19/WA/0043
Date of REC Opinion
14 Feb 2019
REC opinion
Favourable Opinion