An Open-Label Mass Balance Study of [14C]NST-6179 in Healthy Male Subjects QSC300672
Research type
Research Study
Full title
A Phase I, Open-Label, Single-Period, Single-Dose Study to Assess the Absorption, Metabolism, and Excretion of Oral [14C]NST-6179 (Orziloben) in Healthy Male Subjects
IRAS ID
1009695
Contact name
Michelle Yokley
Contact email
Sponsor organisation
NorthSea Therapeutics B.V.
ISRCTN Number
ISRCTN12367117
Research summary
The Sponsor is developing the test medicine, NST-6179, as a potential treatment for intestinal failure associated liver disease (IFALD), also referred to as parenteral nutrition associated liver disease. IFALD is a liver injury that occurs in patients with intestinal failure who are dependent on a lifesaving treatment called Parenteral Nutrition. Parenteral nutrition (PN) is a lifesaving treatment for individuals with intestinal failure (where food is not digested or absorbed properly). This is a way of providing food and nutrients needed in the body by adding them directly into the bloodstream through a vein. However, long-term PN treatment can have potentially serious problems, including liver disease.
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.
* Does the test medicine cause any important side effects?
* 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 non-NHS site in Nottingham.
We plan to enrol up to 8 healthy men aged 30-65 years.
Volunteers will receive a single dose of radiolabelled test medicine, [14C]NST-6179, as 2 capsules by mouth. They’ll stay in the clinic for up to 10 nights, and take up to 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, and up to a maximum of 10 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
HSC REC B
REC reference
24/NI/0061
Date of REC Opinion
27 Jun 2024
REC opinion
Further Information Favourable Opinion