[14C] Study on Mass Balance and Biotransformation of STI-1558 in Healthy Chinese Adult Male Subjects

Summary

This trial adopts a single-center, single-dose, single-period, non-randomized, open-label study design. It is planned to enroll 6\~8 healthy male subjects, and each subject receives single oral administration of drug solution containing 600mg/approximately 100µCi \[14C\]STI-1558 under fasting conditions on trial D1. The whole blood, plasma, urine and stool samples are collected at specified time points/intervals during the trial. The pharmacokinetic parameters of the total radioactivity in plasma and whole blood, the material concentration ratios of the total radioactivity in plasma and whole blood, and the material balances are obtained by testing the total radioactivity of \[14C\]STI-1558 in plasma, whole blood, urine and feces. Meanwhile, using isotope tracer and mass spectrometry techniques, the main pathways and characteristics of metabolism and elimination of STI-1558 in humans are obtained through the quantification of radioactive metabolite profiles and the structure identification of the main metabolites in plasma, urine and feces of the subjects. The entire duration of trial is expected to be 5 months.

Timeline

Start

2023-05-15

Primary completion

2023-06-22

Completion

2023-11-09

Drugs

Indications