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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [14C]-JNT-517 | Experimental | Participants receive a single dose of [14C]-JNT-517, orally, on Day 1 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C]-JNT-517 | Drug | Suspension |
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| Measure | Description | 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 |
| Measure | Description | 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 |
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Inclusion Criteria
Exclusion Criteria
Note: Other protocol-specified inclusion/exclusion criteria may apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fortrea Clinical Research Unit Inc. | Madison | Wisconsin | 53704 | United States |
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| Label | URL |
|---|---|
| Otsuka Clinical Trial Transparency Website | View source |
| Otsuka Clinical Trial Website: | View source |
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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.
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| 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 |
| Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Parameters | Up to Day 9 |