A study to evaluate food and PPI effect on bemcentinib
Research type
Research Study
Full title
A single‐centre, Phase I, randomised, open‐label, three‐period crossover study to evaluate the effect of a high-fat meal and esomeprazole on the pharmacokinetics of a single oral dose of bemcentinib in healthy volunteers
IRAS ID
286639
Contact name
Ezanul Wahab
Contact email
Sponsor organisation
BerGenBio ASA
Eudract number
2020-003158-64
Duration of Study in the UK
0 years, 3 months, 21 days
Research summary
Summary of Research\nThe purpose of this study is to investigate the study drug bemcentinib.\nThe main objectives of this study are as follows:\n\n- To determine the effect of esomeprazole (a drug used to decrease the amount of acid produced in the stomach) on the activity of bemcentinib.\n\n- To investigate the effect of a high fat meal on the activity of bemcentinib when compared to administration of bemcentinib in a fasted state i.e. without food.\n\n- To further investigate the safety of bemcentinib when it is given in a fed or fasted state and after administration of esomeprazole.\n\nIn this study, bemcentinib will be given in the form of an oral capsule. Bemcentinib will be given at a dosage strength of 400 milligrams (mg) in the form of 4 x 100 mg capsules. This study will be split into 3 treatment periods; 1 treatment period taking a single dose of bemcentinib after an overnight fast, 1 treatment period taking a single dose of bemcentinib after consumption of a high fat meal and 1 treatment period taking a single dose of bemcentinib after taking esomeprazole once daily for 6 days. All participants are required to complete all three treatment periods.\n\nResults from each of the treatment periods to determine if there are any significant differences in the activity of bemcentinib.\n\nThe purpose of this is to support the study sponsor in developing guidance as to how the bemcentinib product should be administered in future clinical studies of the product i.e. should the product be taken with or without food and should use of products such as esomeprazole (known as proton pump inhibitors) be avoided when taking the bemcentinib product.\n\nThe study will be conducted in 30 healthy volunteers (males and females) at Simbec-Orion Clinical Pharmacology Unit in Merthyr Tydfil, South Wales.\n\nSummary of Results\nDue to the commercially sensitive and confidential nature of the results surrounding this study and study drug, a summary of the study results will not be publicly available.
REC name
Wales REC 2
REC reference
20/WA/0208
Date of REC Opinion
27 Aug 2020
REC opinion
Further Information Favourable Opinion