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Completed

NCT Number: NCT07573449

How [14C]-JNT-517 is Absorbed, Broken Down, and Removed From the Body After 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.

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Fortrea Clinical Research Unit Inc.

Madison, Wisconsin, 53704, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

[14C]-JNT-517

Drug

Suspension

Primary outcomes

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

    Time frame: Up to Day 9

  2. Relative Amounts Of Radioactivity Excreted in Urine and Feces

    Time frame: Up to Day 9

  3. 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

  4. 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

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

    Time frame: Up to Day 9

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

    Time frame: Up to Day 9

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

    Time frame: Up to Day 9

  8. AUC₀-∞ of Total Radioactivity in Plasma And Whole Blood

    Time frame: Up to Day 9

  9. AUC₀-tlast of Total Radioactivity in Plasma And Whole Blood

    Time frame: Up to Day 9

  10. Cmax of Total Radioactivity in Plasma and Whole Blood

    Time frame: Up to Day 9

  11. Tmax of Total Radioactivity in Plasma and Whole Blood

    Time frame: Up to Day 9

  12. t½ of Total Radioactivity in Plasma and Whole Blood

    Time frame: Up to Day 9

Secondary outcomes

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

    Time frame: Up to Day 9

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

    Time frame: Up to Day 9

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

    Time frame: Up to Day 9

Sponsors and collaborators

Lead sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 7, 2026
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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