Health VolunteersPhase 1NCT07900607
The Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]OD-001 in Healthy Male Participants
A Phase 1 study testing [14C]OD-001 in people with Health Volunteers, run by Odyssey Therapeutics, Inc. at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Health Volunteers
- What is being tested?
- [14C]OD-001
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 31 Oct 2026to Jan 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Quotient Sciences
Ruddington
Study Coordinator, +44 (0)115 974 9000, clinicaltrials@odysseytx.com
About this study
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
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.
- Conditions
- Health Volunteers
- Being tested
- [14C]OD-001
- Keywords
- mass balance, phase 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C]OD-001Drug
[14C]OD-001
| Study group | Role | What they receive |
|---|---|---|
| [14C]OD-001 | Experimental | oral solution Receives: Drug: [14C]OD-001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mass balance recovery of total radioactivity in all excreta: CumAe
Measured: Day 1 to Day 8
Mass balance recovery of total radioactivity in all excreta: Cum%Ae
Measured: Day 1 to Day 8
Number of OD-001 metabolites at ≥10% of total exposure of [14C]-radiolabel in blood
Measured: 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
Measured: Day 1 to Day 8
Secondary outcomes (12)
Rate of elimination of [14C]OD-001 in excreta by Ae
Measured: Day 1 to Day 8
Rate of elimination of [14C]OD-001 in excreta by %Ae
Measured: Day 1 to Day 8
Secondary Rate of elimination of [14C]OD-001 in excreta by CumAe
Measured: Day 1 to Day 8
Rate of elimination of [14C]OD-001 in excreta by Cum%Ae by interval
Measured: Day 1 to Day 8
Incidence of treatment-emergent adverse events
Measured: Day 1 to Day 8
Percentage of [14C] total radioactivity OD-001 metabolites in excreta
Measured: Day 1 to Day 8
Tmax of OD-001 in blood, total radioactivity in blood and plasma
Measured: Day 1 to Day 8
Cmax of OD-001 in blood, total radioactivity in blood and plasma
Measured: Day 1 to Day 8
AUC0-last of OD-001 in blood, total radioactivity in blood and plasma
Measured: Day 1 to Day 8
T1/2 of OD-001 in blood, total radioactivity in blood and plasma
Measured: Day 1 to Day 8
Incidence of abnormal clinical laboratory test results
Measured: Day 1 to Day 8
Incidence of abnormal electrocardiograms (ECGs)
Measured: Day 1 to Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study start31 Oct 2026
- Primary completionDec 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Odyssey Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anthony Opipari, Study director, Odyssey Therapeutics, Inc.Sharan Sidhu, MBChB, BAO, MRCS, MFPM, Principal investigator, Quotient Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07900607
- Sponsor's protocol ID
- OD-001-100
- Status last verified
- Nov 2026
- First submitted
- 5 Oct 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07900607
- Acronym / sponsor ID
- OD-001-100
- Conditions
- Health Volunteers
- Keywords
- mass balance, phase 1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Odyssey Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Oct 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 28 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [14C]OD-001 | Experimental | Drug: [14C]OD-001oral solution |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [14C]OD-001[14C]OD-001 | Drug | [14C]OD-001 |
Primary outcome
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
12 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anthony Opipari study director
Odyssey Therapeutics, Inc.
Sharan Sidhu, MBChB, BAO, MRCS, MFPM principal investigator
Quotient Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing [14C]OD-001 in people with Health Volunteers, run by Odyssey Therapeutics, Inc. at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kelly Bourdon (857-393-6160, clinicaltrials@odysseytx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mass balance recovery of total radioactivity in all excreta: CumAe (time frame: Day 1 to Day 8). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.