Study on [14C]HMPL-453（FGFR Inhibitor） in Healthy Chinese Adult Male Subjects

NCT07644442 | Completed Phase 1

• 1 other identifier: 2024-453-00CH2
• 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-453

Conditions

Mass Balance Study

Outcome Measures

Primary Outcomes (3)

• Human Mass balance

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

  Day-1 ~Day15

• Human Mass balance

  Percentage of the unchanged drug and its metabolites in plasma to total radioactivity exposure levels in plasma; percentage of the unchanged drug and its metabolites in urine and feces to the administered dose; identification of major metabolites in plasma, urine and feces.

  Day-1 ~Day15

• 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 ~Day15

Study Arms (1)

200µCi [14C] HMPL-453

EXPERIMENTAL

After an overnight fast of at least 10 hours, subjects will take \[14C\]HMPL-453 (approximately 200 μCi radioactivity) containing 300 mg HMPL-453 30 minutes after starting breakfast (breakfast must be finished within 30 minutes), and ensure that the entire dose is taken within 10 minutes.

Drug: HMPL-453

Interventions

HMPL-453 DRUG

D1: 300 mg/200 µCi \[14C\] HMPL-453 Single dose

200µCi [14C] HMPL-453

Eligibility Criteria

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

You may qualify if:

• The subjects fully understand the content of the experiment, the process and possible adverse reactions, voluntarily sign the informed consent form, can communicate well with the researchers, and can complete all experimental procedures as specified in the protocol;
• Healthy male subjects aged 18-45 years (inclusive, based on the time of signing the informed consent form);
• Body weight ≥50 kg, body mass index (BMI) 19\~26 kg/m2 (including limit values);
• Subjects must commit to having no plans for pregnancy or sperm donation from the time of signing the informed consent form until 180 days after the end of the study medication administration. If the sexual partner is a female of childbearing potential, then a highly effective method of contraception should also be used.

You may not qualify if:

• History of severe allergies (such as drug allergies) and acute allergic rhinitis or food allergies within 2 weeks prior to screening, allergic to any investigational drug (or its excipients) given in this study;
• History of hypertension, or baseline blood pressure: systolic ≥140 mmHg and/or diastolic ≥90 mmHg;
• Existing or occurring during the screening period clinically abnormal manifestations that need to be excluded (as judged by the researcher), including but not limited to diseases of the nervous/mental system, respiratory system, cardiovascular system, digestive system (any history of gastrointestinal diseases affecting oral or absorption of drugs), blood and lymphatic system, urinary system, endocrine system, immune system;
• History of gastrointestinal surgery, kidney surgery, cholecystectomy, etc., which the researchers judge may affect drug absorption or excretion;
• Abnormal ophthalmological examination results have clinical significance, corrected visual acuity \<1.0 or with the following history of eye diseases: non-arteritic anterior ischemic optic neuropathy (NAION), color vision abnormalities, hereditary retinal degeneration (such as pigmentary retinopathy), macular degeneration, retinal detachment, corneal lesions confirmed by ophthalmological examination, including but not limited to bullous keratopathy, band keratopathy, corneal abrasion, corneal ulcer, keratitis, etc.;
• Anal diseases with periodic/ongoing bleeding;
• History of vomiting and diarrhea within the past week;
• Subjects who have used any prescription drugs within the past 30 days;
• History of any non-prescription drugs and herbal supplements (including but not limited to vitamins, preventive treatments, Chinese herbal medicines, plant-based health products, etc.) taken within the past 14 days;
• Screening period vital signs, physical examination, chest frontal and lateral films, and laboratory tests (including routine blood tests, blood biochemistry, routine urine tests, thyroid function, coagulation function, stool analysis, etc.) results are judged by the researcher to be clinically significant abnormalities (CS);
• During the screening period, clinically significant abnormalities appear on the 12-lead ECG, or baseline QTcF interval \>450 ms, or there is a history of QTc interval prolongation syndrome or sudden death in the family. If the ECG cannot display the QTcF result, please use the following formula to calculate: QTcF=QT/∛RR (RR=60/heart rate);
• Creatinine clearance rate ≤90 mL/min estimated by the Cockcroft-Gault formula \[(140-age) × weight (kg)\] / \[72 × serum creatinine (mg/dL)\];
• Positive for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, HIV antibody, or syphilis spirochete antibody;
• Irregular or difficult bowel movements, or other conditions that the researcher determines may affect stool sample collection;
• Subjects who smoked more than 10 cigarettes per day in the past 3 months, and could not completely quit smoking during the study period;

Sponsors & Collaborators

• Hutchmed: lead

Study Sites (1)

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

Jinan, Shandong, 250000, China

Location

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: February 17, 2025
• First Posted: June 12, 2026
• Study Start: February 26, 2025
• Primary Completion: March 14, 2025
• Study Completion: March 14, 2025
• Last Updated: June 12, 2026

Record last verified: 2026-06

Data Sharing

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

Locations

CN (1)