A Study to Evaluate Metabolism, Excretion, and Mass Balance of [14C]MK-5684 (QSC301809)
Research type
Research Study
Full title
An Open-label Phase 1 Study to Evaluate Metabolism, Excretion, and Mass Balance of [14C]MK-5684 in Healthy Male Participants
IRAS ID
1010197
Contact name
Carol Cannon
Contact email
Sponsor organisation
Merck, Sharpe & Dohme LLC
Clinicaltrials.gov Identifier
Research summary
The Sponsor is developing the test medicine, MK-5684, as a potential treatment for advanced prostate cancer. Cancer is a condition where cells in a specific part of the body grow and reproduce uncontrollably, causing a growth called a tumour. The cancerous cells can invade and destroy surrounding healthy tissue, including organs.
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 addition, 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?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 12 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 up to 12 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
24/NE/0117
Date of REC Opinion
5 Sep 2024
REC opinion
Further Information Favourable Opinion