A Phase 1 interventional study of 19 mg /50 μCi of [¹⁴C] Purinostat Mesylate in MB, sponsored by Chengdu Zenitar Biomedical Technology Co., Ltd. Not yet recruiting at 1 site in China. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by Chengdu Zenitar Biomedical Technology Co., Ltd · Phase 1, Interventional, and Treatment
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.
Chengdu Zenitar Biomedical Technology Co., Ltd is the lead sponsor of 23 studies on the registry; 12 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
- All participants must:1.Chinese healthy adult male, aged 18-45 years old 2.Participants weighing no less than 50 kg and having a (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 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 product (IP)s and its 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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: 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).
Cumulative excretion rate of total radioactivity in urine and feces
Time frame: Through 216 hours postdose
Cmax
Time frame: Through 120 hours postdose
Tmax
Time frame: Through 120 hours postdose
AUC0-t
Time frame: Through 120 hours postdose
t1/2
Time frame: Through 120 hours postdose
Start is estimated for Sep 2026; primary completion for Oct 2026, 1 month later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Chengdu Zenitar Biomedical Technology Co., Ltd →