Mass Balance and Bioavailability Study (QSC204176)
Research type
Research Study
Full title
OPEN-LABEL STUDY TO INVESTIGATE THE MASS BALANCE AND ABSOLUTE BIOAVAILABILITY OF A SINGLE ORAL DOSE OF [14C]-LABELED RO7049389 OR RO7049389 AND AN INTRAVENOUS MICRO-DOSE OF [13C]-LABELED RO7049389 IN HEALTHY VOLUNTEERS
IRAS ID
291819
Contact name
Jessie Zhao
Contact email
Sponsor organisation
F. Hoffmann-La Roche Ltd
Eudract number
2020-005301-70
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 2 months, 23 days
Research summary
Research Summary
The Sponsor is developing the test medicine, RO7049389, for the potential treatment of chronic hepatitis B virus (HBV) infection. HBV infection is a major cause of both acute hepatitis and chronic liver diseases, with approximately 257 million people worldwide living with chronic HBV infection.The study involves radiolabelling (labelling the molecule with radioactive 14C), in the mass balance (MB) cohort, which is used to locate the molecule within the body.
The study aims to characterise the MB (how much radioactivity can be recovered from the urine and faeces) and routes and rates of elimination of the radiolabelled test medicine. It will also determine the absolute oral bioavailability (BA) of the test medicine (the proportion of test medicine entering the body). The study will try to determine the amount of test medicine and its metabolites (breakdown products) in the blood, urine and faeces. Safety and tolerability will also be assessed.
The study will consist of two cohorts. The MB cohort will consist of up to six healthy male Caucasian volunteers who will receive a single dose of radiolabelled test medicine as an oral suspension, followed by an intravenous infusion of the test medicine.
The BA cohort will consist of two periods with up to 16 healthy male and female volunteers, of Caucasian or East Asian ethnicity (eight of each ethnicity). In both periods volunteers will receive a single dose of the test medicine as an oral tablet, followed by an intravenous infusion of the test medicine. The doses will differ in the two periods. There will be a minimum washout period of seven days between dosing.
For all groups, volunteers will receive a follow-up call on approximately Day 29, to ensure their continued wellbeing.
Summary of Results
A lay summary is not available at the time of submission, however a summary of results will be posted on clinicaltrials.gov by the end of 2022. The Sponsor would like to direct readers to clinicaltrials.gov rather than providing a separate lay summary to ensure consistency.REC name
London - London Bridge Research Ethics Committee
REC reference
21/LO/0072
Date of REC Opinion
29 Jan 2021
REC opinion
Favourable Opinion