Healthy VolunteersPhase 1NCT07573449
How [14C]-JNT-517 is Absorbed, Broken Down, and Removed From the Body After a Single Oral Dose in Healthy Male Participants
A Phase 1 study testing [14C]-JNT-517 in people with Healthy Volunteers, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to determine the absorption, metabolism and excretion of [14C]-JNT-517 and to characterize and determine the metabolites present in plasma, urine, and feces in healthy male participants following a single oral administration. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- [14C]-JNT-517
- 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 States
- Study dates
- 22 Jan 2024to 27 Feb 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index (BMI) between 18.0 to 32.0 kilograms per square meter (kg/m^2), inclusive.
- In good health at screening as determined by: a) Medical history, b) Physical examination, c) ECG, d) Clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia [e.g. suspicion of Gilbert's syndrome based on total and direct bilirubin] is not acceptable).
- History of a minimum of 1 bowel movement per day.
- Able to comprehend and are willing to sign the Informed consent form (ICF) and abide by the study restrictions.
Who cannot join
- Use or intend to use any medications/products known to alter drug absorption, metabolism and excretion processes, including St. John's wort, within 30 days prior to dosing, considered to potentially impact participant safety or the objectives of the study, as determined by the investigator or designee.
- Alcohol consumption of >14 units per week.
- A Positive urine drug screen at screening or positive alcohol test result or positive urine drug screen at check-in.
- Participants having taken an investigational drug within 30 days prior to screening.
- Participants who have previously been dosed in >2 radiolabeled drug studies in the last 12 months.
- Participants with exposure to significant diagnostic or therapeutic radiation (e.g. serial X-ray, computed tomography scan, barium meal).
- Previous exposure to JNT-517.
- Note: Other protocol-specified inclusion/exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
United States1 site
Fortrea Clinical Research Unit Inc.
Madison, Wisconsin, 53704
About this study
Official title: A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]JNT-517 Following a Single Oral Dose in Healthy Male Participants
The purpose of this study is to determine the absorption, metabolism and excretion of [14C]-JNT-517 and to characterize and determine the metabolites present in plasma, urine, and feces in healthy male participants following a single oral administration.
- Conditions
- Healthy Volunteers
- Being tested
- [14C]-JNT-517
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C]-JNT-517Drug
Suspension
| Study group | Role | What they receive |
|---|---|---|
| [14C]-JNT-517 | Experimental | Participants receive a single dose of [14C]-JNT-517, orally, on Day 1 Receives: Drug: [14C]-JNT-517 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Radioactivity Recovery (fet1-t2) in Urine and Feces
Measured: Up to Day 9
Relative Amounts Of Radioactivity Excreted in Urine and Feces
Measured: Up to Day 9
Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-∞) of [14C]-JNT-517 And Its Metabolites in Plasma
Measured: Up to Day 9
Area Under The Concentration-Time Curve From Time Zero to The Time Of The Last Quantifiable Concentration (AUC0-tlast) of [14C]-JNT-517 And Its Metabolites in Plasma
Measured: Up to Day 9
Maximum Plasma Concentration (Cmax) of [14C]-JNT-517 And Its Metabolites in Plasma
Measured: Up to Day 9
Time to Reach Maximum (Peak) Observed Plasma Concentration (Tmax) of [14C]-JNT-517 And Its Metabolites in Plasma
Measured: Up to Day 9
Apparent Terminal Elimination Half-Life (t½) of [14C]-JNT-517 And Its Metabolites in Plasma
Measured: Up to Day 9
AUC₀-∞ of Total Radioactivity in Plasma And Whole Blood
Measured: Up to Day 9
AUC₀-tlast of Total Radioactivity in Plasma And Whole Blood
Measured: Up to Day 9
Cmax of Total Radioactivity in Plasma and Whole Blood
Measured: Up to Day 9
Tmax of Total Radioactivity in Plasma and Whole Blood
Measured: Up to Day 9
t½ of Total Radioactivity in Plasma and Whole Blood
Measured: Up to Day 9
Secondary outcomes (3)
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Measured: Up to Day 9
Number of Participants With Clinically Significant Changes in Clinical Laboratory Test Parameters
Measured: Up to Day 9
Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Parameters
Measured: Up to Day 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2026
- Study start22 Jan 2024
- Primary completion22 Jan 2025
- Study completion27 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Otsuka Pharmaceutical Development & Commercialization, Inc.The sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07573449
- Sponsor's protocol ID
- 359-201-00003
- Status last verified
- Apr 2026
- First submitted
- 30 Apr 2026
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Anonymized individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]JNT-517 Following a Single Oral Dose in Healthy Male Participants
- ClinicalTrials.gov ID
- NCT07573449
- Acronym / sponsor ID
- 359-201-00003
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.Industry (pharma, biotech, devices)
- Study start
- 22 Jan 2024 (actual)
- Primary completion
- 22 Jan 2025 (actual)
- Study completion
- 27 Feb 2025 (actual)
- First posted
- 7 May 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.
The purpose of this study is to determine the absorption, metabolism and excretion of [14C]-JNT-517 and to characterize and determine the metabolites present in plasma, urine, and feces in healthy male participants following a single oral administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [14C]-JNT-517 | Experimental | Drug: [14C]-JNT-517Participants receive a single dose of [14C]-JNT-517, orally, on Day 1 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Body mass index (BMI) between 18.0 to 32.0 kilograms per square meter (kg/m^2), inclusive.
- In good health at screening as determined by: a) Medical history, b) Physical examination, c) ECG, d) Clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia [e.g. suspicion of Gilbert's syndrome based on total and direct bilirubin] is not acceptable).
- History of a minimum of 1 bowel movement per day.
- Able to comprehend and are willing to sign the Informed consent form (ICF) and abide by the study restrictions.
Key exclusion criteria (8 listed)
- Use or intend to use any medications/products known to alter drug absorption, metabolism and excretion processes, including St. John's wort, within 30 days prior to dosing, considered to potentially impact participant safety or the objectives of the study, as determined by the investigator or designee.
- Alcohol consumption of >14 units per week.
- A Positive urine drug screen at screening or positive alcohol test result or positive urine drug screen at check-in.
- Participants having taken an investigational drug within 30 days prior to screening.
- Participants who have previously been dosed in >2 radiolabeled drug studies in the last 12 months.
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]-JNT-517Suspension | Drug | [14C]-JNT-517 |
Primary outcome
Total Radioactivity Recovery (fet1-t2) in Urine and Feces
Time frame: Up to Day 9
Relative Amounts Of Radioactivity Excreted in Urine and Feces
Time frame: Up to Day 9
Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-∞) of [14C]-JNT-517 And Its Metabolites in Plasma
Time frame: Up to Day 9
Area Under The Concentration-Time Curve From Time Zero to The Time Of The Last Quantifiable Concentration (AUC0-tlast) of [14C]-JNT-517 And Its Metabolites in Plasma
Time frame: Up to Day 9
Maximum Plasma Concentration (Cmax) of [14C]-JNT-517 And Its Metabolites in Plasma
Time frame: Up to Day 9
Time to Reach Maximum (Peak) Observed Plasma Concentration (Tmax) of [14C]-JNT-517 And Its Metabolites in Plasma
Time frame: Up to Day 9
Apparent Terminal Elimination Half-Life (t½) of [14C]-JNT-517 And Its Metabolites in Plasma
Time frame: Up to Day 9
AUC₀-∞ of Total Radioactivity in Plasma And Whole Blood
Time frame: Up to Day 9
AUC₀-tlast of Total Radioactivity in Plasma And Whole Blood
Time frame: Up to Day 9
Cmax of Total Radioactivity in Plasma and Whole Blood
Time frame: Up to Day 9
Tmax of Total Radioactivity in Plasma and Whole Blood
Time frame: Up to Day 9
t½ of Total Radioactivity in Plasma and Whole Blood
Time frame: Up to Day 9
3 secondary outcomes
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to Day 9
Number of Participants With Clinically Significant Changes in Clinical Laboratory Test Parameters
Time frame: Up to Day 9
Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Parameters
Time frame: Up to Day 9
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Otsuka Clinical Trial Transparency WebsiteLink provided by the sponsor.
- Otsuka Clinical Trial Website:Link provided by the sponsor.
- Individual participant dataSharing planned: No. Anonymized individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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]-JNT-517 in people with Healthy Volunteers, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 1 site in United States.
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 8 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: finished, as of the sponsor's last update on 7 May 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 States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Radioactivity Recovery (fet1-t2) in Urine and Feces (time frame: Up to Day 9). The study lists 12 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 7 May 2026.