* Formulation comparison of evobrutinib in healthy volunteers QSC204743
Research type
Research Study
Full title
A Phase I, Single-site, Open-label, Partially Randomized Study to Evaluate the Relative Bioavailability and Pharmacokinetics of Evobrutinib Following Administration of Different Formulations in Healthy Participants
IRAS ID
308063
Contact name
Angelika Bachmann
Contact email
Sponsor organisation
Merck Healthcare KGaA
Eudract number
2021-005056-11
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 7 months, 14 days
Research summary
The Sponsor is developing the study drug, evobrutinib, for the potential treatment of relapsing multiple sclerosis. There are treatments available, however they have side effects. Therefore, the study drug is being developed to expand treatment options, increase compliance, and reduce patient pill burden.
The purpose of this study is to determine if there is a difference in the amount of study drug that gets into the bloodstream when different forms of the study drug are tested. There are up to 8 different forms of the study drug that are planned to be tested. The study will also determine the safety of the different forms of the study drug, any side effects that might be associated with them and the effect of the study drug on a certain protein in the body will also be evaluated. The study may also evaluate the effect food has on the different forms of the study drug.
This is a two-part, open-label, partially randomized study involving up to 48 healthy male and non-pregnant, non-lactating female volunteers, aged between 18 and 55.
Each volunteer will participate in one part of the study only. In both parts of the study, volunteers will participate in up to 5 study periods. In Periods 1 to 3, volunteers will receive one form of the study drug as a reference, or one of the 8 forms of the study drug being tested. In Period 4, the best forms of the study drug from Periods 1 to 3 will be tested. The best overall form from Period 4 may be further tested in Period 5. Periods 4 and 5 may explore the effect of food on the study drug.
Blood samples and safety assessments will be performed throughout the study and volunteers will return to the clinical unit for safety follow-up visits on Day 29 in Periods 4 and 5. Volunteers will be discharged from the study after the final safety follow-up visit has been completed.
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
22/EE/0207
Date of REC Opinion
25 Jan 2022
REC opinion
Further Information Favourable Opinion