Phase I ADME and Absolute Bioavailability Study (QSC303094)
Research type
Research Study
Full title
A phase I, open-label, two-part trial to investigate the mass balance, metabolism, and basic pharmacokinetics of BI 1819479 (C-14) as an oral solution (part A) and to investigate the absolute bioavailability of BI 1819479 administered as a film-coated tablet together with an intravenous microtracer dose of [14C]BI 1819479 (part B) in healthy male volunteers
IRAS ID
1011464
Contact name
Elmar Daalman
Contact email
Sponsor organisation
Boehringer Ingelheim Pharma GmbH & Co. KG
Clinicaltrials.gov Identifier
Research summary
The Sponsor is developing the test medicine, BI 1819479, as a potential treatment for idiopathic pulmonary fibrosis (IPF). IPF is a condition that causes a person’s lungs to become scarred over time, making breathing increasingly difficult, ultimately resulting in death.
In this study, we’ll give healthy volunteers doses of test medicine (1 in Part A and 2 in Part B) to find out how much enters the blood stream and 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 (Part A)?
*How does the body break down and get rid of the test medicine (Part A)?
*How much of the test medicine gets into the bloodstream (Part B)?
This study will take place at 1 site in Nottingham. We plan to enrol 14 healthy men aged 18-55 years.
Volunteers will take part in 1 study part only. In Part A, volunteers will receive a single oral dose of radiolabelled test medicine, as a liquid by mouth. They’ll stay in the clinic for up to 16 nights, attend up to 5 outpatient visits (3 of which involve an overnight stay at the clinical unit), and take 14 weeks to finish the study. In Part B, volunteers will receive a single dose of test medicine as 2 tablets, and shortly afterwards, a very tiny dose of radiolabelled test medicine by injection into a vein. They’ll stay in the clinic for 4 nights, attend 7 outpatient visits, and take 14 weeks to finish the study.
In both parts, we’ll collect blood and urine samples to do safety tests. In Part A, 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. In Part B, we’ll take many blood samples to measure the amount of test medicine.REC name
London - Surrey Borders Research Ethics Committee
REC reference
25/LO/0285
Date of REC Opinion
26 Jun 2025
REC opinion
Further Information Favourable Opinion