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, 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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: [14C]-JNT-517

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53704
      • Fortrea Clinical Research Unit Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria

1. Body mass index (BMI) between 18.0 to 32.0 kilograms per square meter (kg/m^2), inclusive.
2. 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).
3. History of a minimum of 1 bowel movement per day.
4. Able to comprehend and are willing to sign the Informed consent form (ICF) and abide by the study restrictions.

Exclusion Criteria

1. 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.
2. Alcohol consumption of >14 units per week.
3. A Positive urine drug screen at screening or positive alcohol test result or positive urine drug screen at check-in.
4. Participants having taken an investigational drug within 30 days prior to screening.
5. Participants who have previously been dosed in >2 radiolabeled drug studies in the last 12 months.
6. Participants with exposure to significant diagnostic or therapeutic radiation (e.g. serial X-ray, computed tomography scan, barium meal).
7. Previous exposure to JNT-517.

Note: Other protocol-specified inclusion/exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: [14C]-JNT-517; Participants receive a single dose of [14C]-JNT-517, orally, on Day 1	Drug: [14C]-JNT-517; Suspension

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2024
• Primary Completion (Actual): January 22, 2025
• Study Completion (Actual): February 27, 2025

Study Registration Dates

• First Submitted: April 30, 2026
• First Submitted That Met QC Criteria: April 30, 2026
• First Posted (Actual): May 7, 2026

Study Record Updates

• Last Update Posted (Actual): May 7, 2026
• Last Update Submitted That Met QC Criteria: April 30, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 359-201-00003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No