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Mass Balance Study of [¹⁴C]Purinostat Mesylate for Injection in Healthy Participants
Sponsor: Chengdu Zenitar Biomedical Technology Co., Ltd
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.
Official title: A Single-center, Non-randomized, Open-label, Single-dose Mass Balance Study of [¹⁴C]Purinostat Mesylate for Injection in Healthy Participants
Key Details
Gender
MALE
Age Range
18 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
6
Start Date
2026-09-28
Completion Date
2027-01-31
Last Updated
2026-09-09
Healthy Volunteers
Yes
Conditions
Interventions
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).
Locations (1)
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China