How [14C]-JNT-517 is Absorbed, Broken Down, and Removed From the Body After a Single Oral Dose in… (NCT07573449) | Clinical Trial Compass
CompletedPhase 1
How [14C]-JNT-517 is Absorbed, Broken Down, and Removed From the Body After a Single Oral Dose in Healthy Male Participants
United States8 participantsStarted 2024-01-22
Plain-language 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.
Who can participate
Age range18 Years – 55 Years
SexMALE
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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).
What they're measuring
1
Total Radioactivity Recovery (fet1-t2) in Urine and Feces
Timeframe: Up to Day 9
2
Relative Amounts Of Radioactivity Excreted in Urine and Feces
Timeframe: 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
Timeframe: 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
Timeframe: Up to Day 9
5
Maximum Plasma Concentration (Cmax) of [14C]-JNT-517 And Its Metabolites in Plasma
Timeframe: Up to Day 9
6
Time to Reach Maximum (Peak) Observed Plasma Concentration (Tmax) of [14C]-JNT-517 And Its Metabolites in Plasma
Timeframe: Up to Day 9
7
Apparent Terminal Elimination Half-Life (t½) of [14C]-JNT-517 And Its Metabolites in Plasma
Timeframe: Up to Day 9
8
Trial details
NCT IDNCT07573449
SponsorOtsuka Pharmaceutical Development & Commercialization, Inc.