Remibrutinib PK Study to Assess Effect of Rabeprazole and Omeprazole
Research type
Research Study
Full title
A Phase 1, open-label, 3-group study to assess the effect of rabeprazole and omeprazole on the pharmacokinetics of remibrutinib (LOU064) in healthy participants
IRAS ID
1011955
Contact name
Leander Wyss
Contact email
Sponsor organisation
Novartis Pharma AG
Research summary
This is a phase I, open label (the participants and the study doctor knows which drug is being administered), 3 group study sponsored by Novartis. The population include healthy males and women of non-child bearing potential. The study looks forward at recruiting 75 participants to get 60 completers. The purpose of the study is to evaluate the effect of rabeprazole and omeprazole (both are approved gastric acid reducing agents) on the blood levels of remibrutinib (an investigational drug aims to treat various autoimmune and chronic inflammatory diseases). \nSince remibrutinib dissolves better in acidic conditions, reducing stomach acid (such as acid reducing agents like proton pump inhibitors, etc..) might lower how much of the drug ’remibrutinib’ gets absorbed.\nParticipants will receive remibrutinib and either rabeprazole or omeprazole by mouth.\nRabeprazole, a strong acid-reducing drug, will be tested under fasting conditions to see its maximum impact on remibrutinib absorption. Omeprazole, a weaker but widely used acid-reducing drug, will be tested under both fasting and fed conditions since food can counteract some of the acid suppression. \nThe goal is to understand how these medications might interfere with remibrutinib’s blood levels and hence effectiveness. The study results should provide advice on remiburinib use for patients taking acid-reducing medications like PPIs.\nThe study duration is about 42 days, including 1 confinement period of about 13 days plus up to 28 days for screening. There will be 1 follow up phone call at the end of the study approximately 30 days after the last time you take the study drugs.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
25/NW/0138
Date of REC Opinion
2 Jun 2025
REC opinion
Further Information Favourable Opinion