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

Completed · Phase 1

Conditions studied: Healthy Volunteers

In brief

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.

Key facts

Study ID

NCT07573449

Run by

Otsuka Pharmaceutical Development & Commercialization, Inc.

People needed

8

Starts

2024-01-22

Expected to finish

2025-02-27

Last updated by the study team

2026-05-07

Who can join

Age: 18 and older, up to 55. Sex: male. Healthy volunteers: accepted.

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

Where it is running

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

Full record on ClinicalTrials.gov

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