Phase I ADME/IV Microtracer Study of ODM-111 (QSC301595)
Research type
Research Study
Full title
Pharmacokinetics, Absolute Bioavailability and Excretion Balance After a Single Oral Dose and IV Microtracer Dose of [14C]ODM-111; An Open-Label, Non-Randomised, Single Centre Study in Healthy Male Subjects
IRAS ID
1009963
Contact name
Mary Weatherall
Contact email
Sponsor organisation
Orion Corporation
ISRCTN Number
ISRCTN12728443
Research summary
The Sponsor is developing the test medicine, ODM-111, as a potential treatment for short and long-term pain. Pain is one of the most common reasons for patients to visit health care providers. Currently available medicines to treat pain only provide partial pain relief and can have troublesome side effects.
In this study we’ll give healthy volunteers three single doses of the test medicine to find out how the body breaks down and gets rid of it. Two doses of 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?
*What are the blood levels of the test medicine and how quickly does the body get rid of it?
*How much of the test medicine gets into the bloodstream?
*How does the body break down and get rid of the test medicine?This study will take place at one non-NHS site in Nottingham.
We plan to enrol 8 healthy men aged 30-65 years who will be involved in both parts of the study.
In Part 1, volunteers will receive a single oral dose of test medicine, and then 2.75 hours later a dose of test medicine containing a very tiny amount of radiolabel by injection into a vein. In Part 2, volunteers will receive a dose of test medicine also containing a radiolabel, by mouth. In Part 1 volunteers will stay in the clinic for 4 nights and in Part 2 they will stay for up to 10 nights. There will be a minimum 14-day gap between each study part, and it will take up to 8 weeks to finish the study.
We’ll collect blood and urine samples to do safety tests. We’ll also take blood samples throughout the volunteers’ stay in clinic and they will collect all their urine and faeces, this is so that we can measure the amount of test medicine and its breakdown products.
REC name
HSC REC B
REC reference
24/NI/0060
Date of REC Opinion
26 Jul 2024
REC opinion
Further Information Favourable Opinion