How [14C]-JNT-517 is Absorbed, Broken Down, and Removed From the Body After a Single Oral Dose in Healthy Male Participants

NCT07573449 | Completed Phase 1 FDA Drug

• 1 other identifier: 359-201-00003
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (12)

• Total Radioactivity Recovery (fet1-t2) in Urine and Feces

  Up to Day 9

• Relative Amounts Of Radioactivity Excreted in Urine and Feces

  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

  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

  Up to Day 9

• Maximum Plasma Concentration (Cmax) of [14C]-JNT-517 And Its Metabolites in Plasma

  Up to Day 9

• Time to Reach Maximum (Peak) Observed Plasma Concentration (Tmax) of [14C]-JNT-517 And Its Metabolites in Plasma

  Up to Day 9

• Apparent Terminal Elimination Half-Life (t½) of [14C]-JNT-517 And Its Metabolites in Plasma

  Up to Day 9

• AUC₀-∞ of Total Radioactivity in Plasma And Whole Blood

  Up to Day 9

• AUC₀-tlast of Total Radioactivity in Plasma And Whole Blood

  Up to Day 9

• Cmax of Total Radioactivity in Plasma and Whole Blood

  Up to Day 9

• Tmax of Total Radioactivity in Plasma and Whole Blood

  Up to Day 9

• t½ of Total Radioactivity in Plasma and Whole Blood

  Up to Day 9

Secondary Outcomes (3)

• Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

  Up to Day 9

• Number of Participants With Clinically Significant Changes in Clinical Laboratory Test Parameters

  Up to Day 9

• Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Parameters

  Up to Day 9

Study Arms (1)

[14C]-JNT-517

EXPERIMENTAL

Participants receive a single dose of \[14C\]-JNT-517, orally, on Day 1

Drug: [14C]-JNT-517

Interventions

[14C]-JNT-517 DRUG

Suspension

[14C]-JNT-517

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Otsuka Pharmaceutical Development & Commercialization, Inc.: lead

Study Sites (1)

Fortrea Clinical Research Unit Inc.

Madison, Wisconsin, 53704, United States

Location

Related Links

• Otsuka Clinical Trial Transparency Website
• Otsuka Clinical Trial Website:

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2026
• First Posted: May 7, 2026
• Study Start: January 22, 2024
• Primary Completion: January 22, 2025
• Study Completion: February 27, 2025
• Last Updated: May 7, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)