Study on Mass Balance of [14C]HMPL-306（Isocitrate Dehydrogenase Inhibitor） in Healthy Chinese Adult Male Subjects

NCT06671873 | Completed Phase 1

• 1 other identifier: 2024-306-00CH1
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the absorption, metabolism and excretion in healthy Chinese male subjects after a single oral dose of \[14C\]HMPL-306

Conditions

Mass Balance Study

Outcome Measures

Primary Outcomes (5)

• Human Mass Balance

  Recovery and cumulative recovery of total radioactivity in excreta (urine and feces).

  Day1~Day29

• Human Mass Balance

  Percentage of the unchanged drug and its metabolites in plasma to total radioactivity exposure levels in plasma;

  Day-1~Day29

• Human Mass Balance

  Percentage of the unchanged drug and its metabolites in urine and feces to the administered dose;

  Day-1~Day29

• Human Mass Balance

  Identification of major metabolites in plasma, urine and feces.

  Day-1~Day29

• Human Mass Balance

  PK parameters of total radioactivity in the plasma; Ratio of total radioactivity concentration in whole blood/plasma at different time points.

  Day-1~Day29

Study Arms (1)

100 µCi [14C] HMPL-306

EXPERIMENTAL

After an overnight fasting of at least 10 hours, subjects will receive \[14C\] HMPL-306 containing 250 mg HMPL-306 (approximately 100 μCi radioactivity) 30 minutes after start of breakfast (must be completed within 30 minutes) and ensure that all of the drug is taken within 10 minutes.

Drug: 100 µCi [14C] HMPL-306

Interventions

100 µCi [14C] HMPL-306 DRUG

D1: 250 mg/100 µCi \[14C\] HMPL-306 Single dose

Also known as: 100 µCi [14C] HMPL-306 suspension

100 µCi [14C] HMPL-306

Eligibility Criteria

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

You may qualify if:

• Subjects are fully informed about the contents, procedures and possible adverse reactions of the study, voluntarily sign the informed consent form, and are able to communicate well with investigators and to complete all study procedures specified in the protocol;
• Healthy male subjects who are 18 to 45 years (inclusive) at the time of signing the informed consent form.;
• Weight ≥50 kg, and body mass index (BMI) between 19 - 26 kg/m2 (inclusive);
• Subjects must promise to have no pregnancy plan or sperm donation plan and to use condoms during sexual intercourse from signing the informed consent form until 180 days after end of the study treatment. If the sexual partner is a female of childbearing potential, a highly effective method of contraception should be also used (see Appendix 1 for more information).

You may not qualify if:

• History of serious allergy (e.g., drug allergy) and acute allergic rhinitis or food allergy within two weeks prior to screening;
• Subjects with a history or clinical manifestation of clinically significant metabolic/endocrine, hepatic, renal, hematologic, pulmonary, immunologic, cardiovascular, gastrointestinal, genitourinary, neurologic, or psychiatric diseases within 3 months prior to and during the screening period (judged by investigators);
• Previous history of hypertension;
• Subjects who are positive for hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibody, anti-human immunodeficiency virus (HIV) antibody, or anti-treponema pallidum antibody;
• Smoking more than 10 cigarettes daily within 3 months prior to the screening and inability to refrain from smoking completely during the study period;
• Regular alcohol consumption within 6 months prior to the study, i.e., drinking more than 14 units of alcohol per week (1 unit =360 mL beer or 45 mL liquor with 40% alcohol or 150 mL wine), or positive alcohol breath at screening;
• Presence of drug abuse or dependence, or positive urine screen for drugs of abuse;
• Subjects who have poor venous access, and have a fear of needles, hemophobia or difficulty in blood collection;
• Having participated in clinical trials for other drugs within 3 months prior to the screening;
• Workers who need to be exposed to radioactive condition for a long term; or those who have significant radiation exposure (≥2 times of chest/abdominal computerised tomography (CT), or ≥3 times of other kinds of X-ray examinations) within 1 year prior to administration, or have participated in the radiopharmaceutical labeling study;
• Subjects who have been vaccinated within 30 days prior to administration and who have a plan for vaccination within 2 weeks after administration;
• According to the investigator's judgment, the subjects have any other disease or status that may affect the normal completion of the study or the evaluation of the study data, or have any other condition that is not suitable for the study.

Sponsors & Collaborators

• Hutchmed: lead

Study Sites (1)

The First Affiliated Hospital of Shandong First Medical University (Shandong Provincial Qianfoshan Hospital)

Jinan, China

Location

Study Officials

• Wei Zhao, offices director

  The First Affiliated Hospital of Shandong First Medical University (Shandong Provincial Qianfoshan Hospital)

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 29, 2024
• First Posted: November 4, 2024
• Study Start: November 26, 2024
• Primary Completion: February 28, 2025
• Study Completion: July 2, 2025
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR

Locations

CN (1)