An ADME Study of [14C]Vapendavir in Healthy Male Subjects (QSC302508)
Research type
Research Study
Full title
An Open-label, Single-dose Study to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]Vapendavir in Healthy Male Subjects
IRAS ID
1010667
Contact name
Katherine Laessig
Contact email
Sponsor organisation
Altesa BioSciences Inc.
Clinicaltrials.gov Identifier
Research summary
The Sponsor is developing the test medicine, vapendavir, as a potential treatment for rhinovirus (RV). RVs are the most frequent cause of the common cold. They are primarily associated with upper respiratory tract (the nose and mouth for example) infections but can cause lower respiratory tract (the lungs and windpipe) infection also.
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 it. 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. We also want to get more information on the safety and tolerability of the test medicine, its metabolites (breakdown products) and any side effects.
This study will take place at 1 non-NHS site in Nottingham. We plan to enrol 8 healthy men aged 30 to 65 years.
Volunteers will receive a single dose of radiolabelled test medicine, as multiple capsules by mouth. They’ll stay in the clinic for up to 10 nights and take up to 5.5 weeks to finish the study.
We’ll collect blood and urine samples to do safety tests. Over a period of at least 8 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.
REC name
North East - York Research Ethics Committee
REC reference
25/NE/0001
Date of REC Opinion
7 Feb 2025
REC opinion
Further Information Favourable Opinion