Bioavailability of KD025 in Healthy Male Subjects (QCL117415)
Research type
Research Study
Full title
A Three Way Crossover, Randomised, Open-Label Study in Healthy Subjects, Designed to Compare the Bioavailability of a KD025 Tablet Formulation Administered in the Fed and Fasted States and to Assess the Relative Bioavailability of a Tablet and Capsule Formulation in the Fed State
IRAS ID
186627
Contact name
Mark Berger
Contact email
Sponsor organisation
Kadmon Corporation
Eudract number
2015-002832-42
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 1 months, 3 days
Research summary
The Sponsor is developing the study drug, KD025, for the potential treatment of a range of diseases, such as autoimmune disease and idiopathic pulmonary fibrosis (condition of the lungs causing scarring).
The study will try to identify how well a tablet form of the study drug is taken up by the body when given with and without food, in comparison with a capsule form of the study drug when given with food.
The study will consist of 3 study periods involving up to 24 healthy male subjects. In Study period 1, up to 12 subjects will receive one of the following treatments; a dose of 200mg KD025 tablet (study drug) in a fasted state (without food), a dose of 200mg study drug in a fed state (with food) or a dose of 200mg KD025 as a drug in capsule (reference drug) in the fed state. In study periods 2 and 3, the subjects will receive one of the other treatments. There will be a break of at least 6 days between each study period.
REC name
HSC REC B
REC reference
15/NI/0154
Date of REC Opinion
20 Aug 2015
REC opinion
Favourable Opinion