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Starting soon Phase 1

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

NCT07900607 · tracked via the Priya Life Science UK tracker
Sponsor
Odyssey Therapeutics, Inc
Phase
Phase 1
Started
2026-10
Last updated
2026-10-28

Condition(s) studied

Health Volunteers

Investigational drug(s) / intervention(s)

[14C]OD-001

[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

Sex
MALE
Min age
30 Years
Max age
65 Years
Healthy volunteers
Accepted
Inclusion Criteria: * Aged 30 to 65 years inclusive at the time of signing informed consent * Must agree to adhere to the contraception requirements. In addition, vasectomised male participants with partners of childbearing potential must have received medical assessment of the surgical success of the procedure Healthy male participants according to the assessment of the Investigator, as based on a complete medical history including a physical examination, vital signs, single 12-lead ECGs, and laboratory safety tests without any clinically significant abnormalities as measured at screening. ECGs and vital signs to be re-checked at pre-dose. * Body mass index (BMI) of 18.0 to 35.0 kg/m2 as measured at screening. * Must have regular bowel movements (i.e. average stool production of ≥1 and ≤3 stools per day). Exclusion Criteria: * Presence or history of clinically significant allergy requiring treatment, as judged by the Investigator. Hay fever is allowed unless it is active. * History of clinically significant cardiovascular, renal, hepatic, dermatological, respiratory, particularly GI disease, especially peptic ulceration, clinically significant GI bleeding, UC, CD, Irritable Bowel Syndrome or malabsorption syndrome that may impair bioavailability, and neurological or psychiatric disorder * Participants who are unable to take oral medication. * Acute diarrhea, constipation or vomiting in the 7 days before the predicted Day 1. If screening occurs \>7 days before Day 1his criterion will be determined on Day 1. Diarrhoea will be defined as the passage of liquid faeces and/or a stool frequency of greater than three times per day. Constipation will be defined as a failure to open the bowels more frequently than every other day

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)

FacilityCityRegionStatus
Quotient Sciences Ruddington United Kingdom
Official registry record

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