Study to evaluate the effect of Itraconazole and Carbamazepine on Fenebrutinib pharmacokinetics
Research type
Research Study
Full title
A Phase I, Open-Label, Single-Dose, Fixed-Sequence, Two-Part Study to Evaluate the Effect of Itraconazole and Carbamazepine on Fenebrutinib Pharmacokinetics in Healthy Subjects
IRAS ID
1009824
Contact name
Head of CTRM Product Development Regulatory
Contact email
Sponsor organisation
F. HOFFMANN-LA ROCHE LTD
ISRCTN Number
ISRCTN12005942
Research summary
The Study Drug (Fenebrutinib) is an investigational drug being developed by the sponsor as a potential treatment for multiple sclerosis (MS) which is a debilitating disease affecting the brain and spinal cord. \nThis study will be a drug-interaction study to investigate the effect of 2 approved drugs on fenebrutinib. \nWhen drugs are taken together, the effectiveness or safety of one or all of the drugs used in combination may be affected. Therefore, it is important to understand the potential drug drug interactions that may occur in order to prevent unwanted and possibly dangerous side effects or loss of effectiveness.\n\nThe study will be in 2 parts (Part 1 and Part 2). Healthy participants will participate in either Part 1 or 2. \n\nThe main purpose of Part 1 of the Study is to evaluate the effect of multiple doses of itraconazole (an approved medication for the treatment of certain fungal infections) on the amount of fenebrutinib that reaches the blood stream and how long the body takes to get rid of fenebrutinib.\n\nThe main purpose of Part 2 of the Study is to evaluate the effect of multiple doses of carbamazepine (an approved medication for the treatment of seizures and certain kinds of pain) on the amount of fenebrutinib that reaches the blood stream and how long the body takes to get rid of fenebrutinib.\n\nApproximately 15 people will participate in Part 1 of this Study and about 17 people will participate in Part 2 of this Study.\nPlanned study duration is approximately 7 weeks (Part 1) and 8 weeks (Part 2)\nThis Study is for research purposes only and is not intended to treat any medical condition.
REC name
London - Brent Research Ethics Committee
REC reference
24/LO/0307
Date of REC Opinion
14 Jun 2024
REC opinion
Further Information Favourable Opinion