Phase 1 Study (QSC302244)
Research type
Research Study
Full title
An Open Label, Single-dose, Single-period Study Designed to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]GRT6019 in Healthy Male Participants
IRAS ID
1013309
Contact name
Wasif Aziz
Contact email
Sponsor organisation
Grünenthal GmbH
Clinicaltrials.gov Identifier
Research summary
The Sponsor is developing the test medicine, GRT6019, as a potential treatment for Duchenne muscular dystrophy. Muscular dystrophy is a rare genetic condition that causes muscle weakness and wasting that gets worse over time.
In this trial, we’ll give healthy volunteers a single dose of test medicine to find out how the body breaks down and gets rid of the test medicine. The test medicine will be ‘radiolabelled’ - it will contain a small amount of radioactivity (Carbon-14) - so that we can track it in the body.
In this trial in healthy volunteers, we aim to answer these questions.
* How much test medicine enters the bloodstream and how quickly does the body get rid of it?
* How does the body break down and get rid of the test medicine?This trial will take place at 1 site in Nottingham.
We plan to enrol 10 healthy men aged 30-65 years.
Volunteers will receive a single dose of radiolabelled test medicine. They’ll stay in the clinic for up to 22 nights, attend if required, up to 4 outpatient visits each involving an overnight stay, and take approximately 11 weeks to finish the trial.
We’ll collect blood and urine samples to do safety tests. Over a period of at least 22 days, we’ll take many blood samples and volunteers will collect all their urine and faeces so that we can measure the amount of test medicine and its breakdown products. We’ll also collect urine and faeces at the 4 return visits, if required, to measure the amount of test medicine and its breakdown products.
REC name
HSC REC B
REC reference
26/NI/0005
Date of REC Opinion
20 Mar 2026
REC opinion
Favourable Opinion