Mass Balance Study of [¹⁴C]Purinostat Mesylate for Injection in Healthy Participants

Condition(s) studied

Investigational drug(s) / intervention(s)

19 mg /50 μCi of [¹⁴C] Purinostat Mesylate: Participants received a single intravenous infusion of \[14C\]Purinostat Mesylate under fasting conditions. The dose was set at the clinically proposed standard dosage (approximately 19 mg per person, administered once, with a radioactive activity of 50 μCi).

Study summary

This trial adopts a single-center, open-label, non-randomized, single-dose study design. It is planned to enroll 6 healthy Chinese male participants, and the final standard is to collect complete samples and data to be tested from at least 6 participants.

After each participant receives a single intravenous infusion of 19 mg (approximately 50 μCi) of \[¹⁴C\] Purinostat Mesylate for Injection on the first day of the trial, whole blood, plasma, urine and feces samples will be collected at specified time points/time periods during the trial. By measuring the total radioactivity, the whole blood-to-plasma ratio of total radioactivity, the pharmacokinetic parameters of total, recovery rate and excretion route data of the total radioactivity in whole blood (if applicable) and plasma.

Eligibility

Primary outcome measure(s)

• Cumulative excretion rate of total radioactivity in urine and feces — Through 216 hours postdose

Trial sites (1)

More Chengdu Zenitar Biomedical Technology Co., Ltd trials in China