The Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]OD-001 in Healthy Male Participants
Condition(s) studied
Investigational drug(s) / intervention(s)
[14C]OD-001: \[14C\]OD-001
Study summary
This study looks at how the body handles an investigational drug called OD-001. Researchers want to learn how the medicine is absorbed, how it is broken down, and how it leaves the body.
About 8 healthy men will join the study, so that at least 6 people complete it. Each participant will drink a single dose of OD-001 as a liquid. This will be done on an empty stomach, so each participant will be asked not to eat for a period of time beforehand.
The medicine contains a small amount of a radioactive "tracer" (carbon-14). The tracer lets researchers follow the medicine and its breakdown products through your body. The amount of radioactivity is small and carefully limited. After the dose, researchers will collect samples such as blood, urine and stool. These will show how much of the medicine is recovered and what it turns into in the body.
Eligibility
Primary outcome measure(s)
- Mass balance recovery of total radioactivity in all excreta: CumAe — Day 1 to Day 8
- Mass balance recovery of total radioactivity in all excreta: Cum%Ae — Day 1 to Day 8
- Number of OD-001 metabolites at ≥10% of total exposure of [14C]-radiolabel in blood — Day 1 to Day 8
- Identity of OD-001 metabolites at ≥10% of total exposure of [14C]-radiolabel in blood by LC-MS and NMR — Day 1 to Day 8
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Quotient Sciences | Ruddington | United Kingdom |
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07900607 on ClinicalTrials.gov ↗ ← All trials in the UK