Study Assessing the Mass Balance, Pharmacokinetics, and Metabolite Profiles of [14C]-INCB099280
Research type
Research Study
Full title
An Open-Label Study Assessing the Mass Balance, Pharmacokinetics, and Metabolite Profiles of a Single Oral Dose of [14C]INCB099280 in Healthy Male Participants
IRAS ID
1009235
Contact name
Carol Penning
Contact email
Sponsor organisation
Incyte Corporation
Research summary
The Sponsor is developing the test medicine, INCB099280, as a potential treatment for advanced malignancies. Advanced malignancies are cancers that have spread from their original site of origin or that have come back after initial treatment.
In this study, we’ll give healthy participants two single doses of test medicine on one occasion to find out how the body breaks down and gets rid of the test medicine. One dose 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 participants, 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 non-NHS site in Nottingham (Quotient). We plan to enrol 7 healthy men aged 35-55 years.
Participants will be admitted to the clinical unit and following an overnight fast, volunteers will receive a single dose of the non-radiolabelled test medicine as 6 tablets by mouth. Approximately 10 minutes afterwards, they will receive a 240 mL oral solution of the radiolabelled test medicine by mouth. They’ll stay in the clinic for at least 6 nights (up to 12 nights if the discharge criteria are not met), have one follow-up phone call 18-24 days post-dose and take up to 8 weeks to finish the study.
We’ll collect blood and urine samples to do safety tests. Over a period of at least 6 days, we’ll take many blood samples and participants will collect all their urine and faeces so that we can measure the amount of test medicine and its breakdown products.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
24/SC/0004
Date of REC Opinion
12 Apr 2024
REC opinion
Further Information Favourable Opinion