MB
Conditions
Brief 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.
Interventions
DRUG19 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).
Sponsors
Chengdu Zenitar Biomedical Technology Co., Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
\- All participants must:1.Chinese healthy adult male, aged 18-45 years old 2.Participants weighing no less than 50 kg and having a body mass index (BMI) between 19.0 and 26.0 kg/m\^2 3.Fully understand the purpose and requirements of this trial, voluntarily participate in the clinical trial and sign a written informed consent form, and be able to complete the entire trial process according to the trial requirements.
Exclusion criteria
\- Participants must not：1.Those with allergic predisposition, such as those with a known history of allergies to two or more substances, or those with allergic diseases, or those who are severely allergic to the investigational product (IP)s and its excipients or HDAC inhibitors; 2.Those with habitual constipation or diarrhea, a history of malabsorption syndrome, or a history of severe nausea, vomiting, diarrhea, or constipation within one week before the screening period; 3.Those who have taken any clinical trial drugs or participated in any other clinical trials within 3 months before screening; 4.Be alcohol dependent or drug abusers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cumulative excretion rate of total radioactivity in urine and feces | Through 216 hours postdose |
Secondary
| Measure | Time frame |
|---|---|
| Cmax | Through 120 hours postdose |
| Tmax | Through 120 hours postdose |
| AUC0-t | Through 120 hours postdose |
| t1/2 | Through 120 hours postdose |
Countries
China
Contacts
CONTACTWang Fangmei
Outcome results
None listed