A Phase 1 interventional study of [14C]OD-001 in Health Volunteers, sponsored by Odyssey Therapeutics, Inc.. Recruiting at 1 site in United Kingdom. Open to male participants aged 30 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Odyssey Therapeutics, Inc. · Phase 1, Interventional, and Other
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.
This is the only study on the registry with Odyssey Therapeutics, Inc. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
oral solution
Drug: [14C]OD-001
\[14C\]OD-001
Mass balance recovery of total radioactivity in all excreta: CumAe
Time frame: Day 1 to Day 8
Mass balance recovery of total radioactivity in all excreta: Cum%Ae
Time frame: Day 1 to Day 8
Number of OD-001 metabolites at ≥10% of total exposure of [14C]-radiolabel in blood
Time frame: 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
Time frame: Day 1 to Day 8
Rate of elimination of [14C]OD-001 in excreta by Ae
Time frame: Day 1 to Day 8
Rate of elimination of [14C]OD-001 in excreta by %Ae
Time frame: Day 1 to Day 8
Secondary Rate of elimination of [14C]OD-001 in excreta by CumAe
Time frame: Day 1 to Day 8
Rate of elimination of [14C]OD-001 in excreta by Cum%Ae by interval
Time frame: Day 1 to Day 8
Incidence of treatment-emergent adverse events
Time frame: Day 1 to Day 8
Percentage of [14C] total radioactivity OD-001 metabolites in excreta
Time frame: Day 1 to Day 8
Tmax of OD-001 in blood, total radioactivity in blood and plasma
Time frame: Day 1 to Day 8
Cmax of OD-001 in blood, total radioactivity in blood and plasma
Time frame: Day 1 to Day 8
AUC0-last of OD-001 in blood, total radioactivity in blood and plasma
Time frame: Day 1 to Day 8
T1/2 of OD-001 in blood, total radioactivity in blood and plasma
Time frame: Day 1 to Day 8
Incidence of abnormal clinical laboratory test results
Time frame: Day 1 to Day 8
Incidence of abnormal electrocardiograms (ECGs)
Time frame: Day 1 to Day 8
Plan to share: Undecided
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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