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NOT YET RECRUITING
NCT07900607
PHASE1

The Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]OD-001 in Healthy Male Participants

Sponsor: Odyssey Therapeutics, Inc.

View on ClinicalTrials.gov

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.

Official title: An Open Label, Single-Dose, Single-Period Study Designed to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]OD-001 in Healthy Male Participants

Key Details

Gender

MALE

Age Range

30 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

8

Start Date

2026-10

Completion Date

2027-01

Last Updated

2026-10-28

Healthy Volunteers

Yes

Interventions

DRUG

[14C]OD-001

\[14C\]OD-001

Locations (1)

Quotient Sciences

Ruddington, United Kingdom