Healthy Volunteers
Conditions
Brief 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.
Interventions
DRUG[14C]-JNT-517
Suspension
Sponsors
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
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/
Design outcomes
Primary
| 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
| 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 |
Countries
United States
Outcome results
None listed