Study to compare different Fenebrutinib tablets and the effect of food and pH on Fenebrutinib in HV
Research type
Research Study
Full title
A Phase I, Open-Label, Randomized, 2-Part Study to Evaluate the Bioequivalence of Single Oral Doses of 2 Different Formulations of Fenebrutinib and the Effect of Food and Rabeprazole on the Pharmacokinetics of Fenebrutinib in Healthy Subjects
IRAS ID
1009864
Contact name
Head of CTRM Product Development Regulatory
Contact email
Sponsor organisation
F. Hoffmann-La Roche Ltd.
ISRCTN Number
ISRCTN23183841
Research summary
This will be a Phase I, open-label (not blinded), single-dose, randomized, 2-part study to evaluate the bioequivalence [a measurement of whether the active ingredient from the two preparations gets into the bloodstream in similar amounts] (Part 1), effect of food and effect of rabeprazole (a drug to reduce stomach acidity) (Part 2) on fenebrutinib blood levels in healthy male and female subjects. Subjects will be assigned to a study part. Parts 1 and 2 may be conducted at the same time and subjects will only be allowed to participate in a single part of the study.\nPart 1 will assess the bioequivalence of the to-be-marketed 200 mg film-coated tablet formulation (1 × 200 mg) to the reference Phase III film-coated tablet formulation (2 × 100 mg) in the fasted state and evaluate the blood levels of both formulations. An exploratory objective of Part 1 is to evaluate substances in blood which demonstrate drug efficacy of both preparations.\nPart 1 is a randomized, open-label, 2-treatment, 2-sequence, design in which sixty subjects are planned for enrolment. On Day 1 of Period 1, subjects will be randomly assigned to 1 of 2 possible treatment sequences (ABAB* or BABA) and both groups will receive fenebrutinib.\nPart 2 will assess the effect of a high-fat meal and rabeprazole (a drug to reduce stomach acidity) on the blood levels of both formulations.\nOn Day 1 of Period 1, subjects will be randomly assigned to 1 of 4 treatment sequences (CDE*, CDF, DCE, and DCF) and fenebrutinib and rabeprazole (where applicable) will be administered based on the assigned sequence.\nBoth Parts will evaluate safety and side effects.\nA total of 84 healthy volunteer male and female subjects will be enrolled (60 subjects in Part 1 and 24 subjects in Part 2).
Lay Summary of Results:
Layman’s summary will generate by Roche and be posted to https://forpatients.roche.com/
REC name
London - Surrey Borders Research Ethics Committee
REC reference
24/LO/0228
Date of REC Opinion
10 Jun 2024
REC opinion
Further Information Favourable Opinion