* Relative Bioavailability, Preliminary Dose Proportionality and FE Study of RO7486967 (QSC205468)
Research type
Research Study
Full title
A Two-part, Open-label, Randomised, Cross-over Study to Compare New Tablet Formulations of RO7486967 to the Capsule Formulation, to Perform a Preliminary Dose Proportionality Assessment and to Estimate the Effect of Food on the Pharmacokinetics of the Tablet Formulations in Healthy Participants
IRAS ID
1004383
Contact name
Head of EU Product Development Regulatory
Contact email
Sponsor organisation
F. Hoffmann-La Roche Ltd
Eudract number
2021-005215-31
ISRCTN Number
ISRCTN14438276
Research summary
The Sponsor is developing new recipes of the test medicine, RO7486967, to potentially treat diseases such as; Inflammatory bowel disease, respiratory diseases including chronic obstructive pulmonary disease and severe asthma and Parkinson’s disease. These diseases are linked by a type of inflammation caused by a protein called NLRP3. The test medicine (RO7486967) is anticipated to reduce this inflammation by specifically targeting and blocking NLRP3 from being activated.
This study will take place at 1 non-NHS site, enrolling up to 31 healthy male and non-pregnant, non-lactating female volunteers aged 18 to 55 years.
This two-part healthy volunteer study is testing up to 3 different recipes of the test medicine, and how they are affected when taken with food. The frequency of adverse events and how the recipes of the test medicine are tolerated will also be investigated. Results from Part 1 will determine if Part 2a or Part 2b is selected.
In Part 1 and Part 2a, the test medicine will be given on 3 occasions and in Part 2b on 4 occasions. In all parts, volunteers will all receive the same recipes of the test medicine, but in a different order; the order will be assigned by chance. Volunteers will receive an oral dose of a new recipe of the test medicine in the fed or fasted state. In Part 1 and Part 2b, volunteers will also receive the test medicine that will be compared with the other recipes in the fasted state. Volunteers will be discharged from the clinic 48 hours post-dose and there will be a break of at least 7 days in between each dosing occasion.
Volunteers will be discharged 48 hours after their final dose and will return to the clinic for a follow-up visit 14 to 21 days later.
Volunteer’s blood and urine will be collected throughout the study for analysis of the test medicine and for their safety.
Volunteers are expected to be involved in this study for approximately 10 weeks for Part 1 and 11 weeks for Part 2, from screening to the follow-up visit.REC name
London - Hampstead Research Ethics Committee
REC reference
22/FT/0053
Date of REC Opinion
27 May 2022
REC opinion
Further Information Favourable Opinion