Phase I Trial (QSC303398)
Research type
Research Study
Full title
A Phase I, open-label, non-randomized study to assess the absorption, distribution, metabolism and excretion (ADME) and pharmacokinetics of LXE408 following a single oral dose of [14C]LXE408 in healthy male participants
IRAS ID
1012840
Contact name
Fiona Morris
Contact email
Sponsor organisation
Novartis Pharma UK ltd
ISRCTN Number
ISRCTN18283468
Research summary
The Sponsor is developing the test medicine, LXE408, to treat diseases such as Chagas disease and leishmaniasis which are caused by parasites. The study medicine works by preventing the cells of the parasites from breaking down proteins properly. This causes toxic proteins to build up inside the cells which die, ultimately killing the parasite.
In this study, 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 study 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 study will take place at 1 site in Nottingham.
We plan to enrol 8 healthy men aged 30-55 years.
Volunteers will receive a single dose of radiolabelled test medicine, as a liquid by mouth. They’ll stay in the clinic for up to 10 nights, attend up to 5 outpatient visits (4 of which involve an overnight stay at the clinical unit), and take up to 11 weeks to finish the study.
We’ll collect blood and urine samples to do safety tests. Over a period of at least 11 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 will also collect samples of expired air and bile whilst volunteers are resident in the clinic.REC name
South Central - Berkshire Research Ethics Committee
REC reference
25/SC/0313
Date of REC Opinion
6 Jan 2026
REC opinion
Further Information Favourable Opinion