* Study of effects of Formulation and API Particle Size on the PK of Fenebrutinib (QSC206109)
Research type
Research Study
Full title
A Phase 1, Single Center, Randomized, Open-Label Study Investigating the Effect of Formulation, and Active Pharmaceutical Ingredient Particle Size on the Pharmacokinetics of Fenebrutinib in Healthy Subjects
IRAS ID
1005691
Contact name
Eric Olson
Contact email
Sponsor organisation
Genentech, Inc.
Eudract number
2022-000888-42
ISRCTN Number
ISRCTN17780768
Research summary
The Sponsor is developing the test medicine, Fenebrutinib, for the potential treatment of Multiple sclerosis (MS). MS is a condition that can affect the brain and spinal cord, causing a wide range of potential symptoms, including problems with vision, arm or leg movement, sensation or balance, and affects approximately 2.3 million people worldwide.
There are medical procedure available that may involve piercing or cutting into the body or inserting instruments (invasive treatments) that target a type of white blood cells called B-cells have been shown to be an effective treatment of MS, however, the Sponsor is developing a medicine that can be taken orally (by mouth) which would provide a less invasive therapeutic option for patients with MS.
This 3-part healthy volunteer trial will try to identify how new recipes (formulations) of the test medicine are taken up by the body (pharmacokinetics), the level of test medicine in the blood following oral dosing (relative bioavailability) and try to provide additional safety and tolerability information for the test medicine.
This study will take place at 1 non-NHS site, enrolling up to 46 male volunteers and female volunteers of non-childbearing potential, aged between 18 and 60.
In Part 1 and Part 2, up to 15 volunteers will receive single oral doses of different recipes of the test medicine across 3 periods.
Part 3 is optional, and if utilized, up to 16 volunteers will receive single doses of different recipes of the test medicine across 2 periods.
In each part, volunteers will be discharged on Day 3 of the final period and will receive a follow up phone call 7 – 10 days post final dose.
Volunteer’s blood and urine will be taken throughout the study for analysis of the test medicine and for their safety.
Volunteers are expected to be involved in this study for 7 weeks for Part 1 and Part 2, and 6 weeks for Part 3, from screening to the follow up call.
Lay Summary of Results
A lay summary of study results has been uploaded to the following location: https://forpatients.roche.com/en/trials/healthy-volunteers/a-study-medicine--fenebrutinib--manufactured-in-different-ways--.html
Has the registry been updated to include summary results? No
If yes - please enter the URL to summary results n/a
If no – why not? n/a
Did you follow your dissemination plan submitted in the IRAS application form (Q A51)? Yes
If yes, describe or provide URLs to disseminated materials The clinical trial report has been distributed to the regulatory authorities, in line with the dissemination plan. As this is a Phase I healthy volunteer study whose results are commercially sensitive, no further publications or presentations are currently planned.
If pending, date when dissemination is expected n/a
If no, explain why you didn't follow it n/a
Have participants been informed of the results of the study? Yes
If yes, describe and/or provide URLs to materials shared and how they were shared Participants are being sent a thank you letter which includes the following link to a lay summary of results for the study: https://forpatients.roche.com/en/trials/healthy-volunteers/a-study-medicine--fenebrutinib--manufactured-in-different-ways--.html
If pending, date when feedback is expected n/a
If no, explain why they haven't n/a
Have you enabled sharing of study data with others? No
If yes, describe or provide URLs to how it has been shared n/a
If no, explain why sharing hasn't been enabled The findings of this Phase I study have been shared with the Sponsor, Genentech Inc., only. As these findings are confidential owing to commercial sensitivity, it is not appropriate to share the results of this study with other researchers at this time.
Have you enabled sharing of tissue samples and associated data with others? No
If yes, describe or provide a URL n/a
If no, explain why Not applicable as this study is a Phase I trial in healthy volunteers whose results are commercially sensitive.REC name
London - Surrey Borders Research Ethics Committee
REC reference
22/FT/0080
Date of REC Opinion
8 Aug 2022
REC opinion
Further Information Favourable Opinion