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

NCT07809217 | Not Yet Recruiting Phase 1

• 1 other identifier: ZLPM-008-MB
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

MB

Outcome Measures

Primary Outcomes (1)

• Cumulative excretion rate of total radioactivity in urine and feces

  Through 216 hours postdose

Secondary Outcomes (4)

• Cmax

  Through 120 hours postdose

• Tmax

  Through 120 hours postdose

• AUC0-t

  Through 120 hours postdose

• t1/2

  Through 120 hours postdose

Study Arms (1)

Purinostat Mesylate

EXPERIMENTAL

Drug: 19 mg /50 μCi of [¹⁴C] Purinostat Mesylate

Interventions

19 mg /50 μCi of [¹⁴C] Purinostat Mesylate DRUG

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).

Purinostat Mesylate

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \- 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Chengdu Zenitar Biomedical Technology Co., Ltd: lead

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, china, China

Location

Central Study Contacts

Wang Fangmei

CONTACT

+8613808086495; fangmei.wang@zenitar.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2026
• First Posted: September 9, 2026
• Study Start: September 28, 2026
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: September 9, 2026

Record last verified: 2026-08

Locations

CN (1)