Human Mass Balance of [14C]HMPL-523 in Healthy Adult Male Chinese Subjects

Phase 1

Completed

• Conditions: Imumune Thrombocytopenia(ITP) Human Mass Balance
• Interventions: Drug: HMPL-523; Drug: 150 µCi [14C]HMPL-523

• Registration Number: NCT05781906
• Lead Sponsor: Hutchmed

Brief Summary

To evaluate the absorption, metabolism and excretion of HMPL-523 in healthy male Chinese subjects following multiple oral doses of HMPL-523 tablets followed by a single oral dose of \[14C\]HMPL-523 suspension

Detailed Description

a single-center, non-randomized, open-label, human mass balance, phase 1 study to evaluate the absorption, metabolism and excretion following multiple oral doses of HMPL-523 tablets, followed by a single oral dose of 300 mg/150 µCi \[14C\]HMPL-523 suspension in healthy adult male Chinese subjects.

Study Timeline

• Study First Submitted: 2023-02-07
• Study Start: 2023-02-08
• Study First Submitted QC: 2023-03-12
• Study First Posted: 2023-03-23
• Primary Completion: 2023-06-01
• Study Completion: 2023-12-06
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-15
• Last Update Posted: 2024-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 6

Inclusion Criteria

1. Subjects who have voluntarily participated in the study and signed the informed consent form with good compliance;
2. Healthy male subjects aged 18-40 years (inclusive);
3. Subjects weighing ≥ 50 kg
4. Subjects in good health status

Exclusion Criteria

1. Subjects with a history of gastrointestinal surgery, renal surgery, cholecystectomy and other procedures that in the judgment of the investigator may affect drug absorption or excretion
2. hypersensitivity to the investigational product and its excipients
3. Subjects with diseases affecting the absorption, distribution, metabolism and excretion of oral drugs,
4. Subjects with fear of needles, hemophobia, difficulty collecting venous blood, or special requirements for diet, who cannot comply with uniform diet
5. Subjects who are abnormal with clinical significance for C-reactive protein or positive for coronavirus nucleic acid detection in coronavirus infection screening
6. Subjects who have participated in another clinical trial of other drugs and have received such investigational product within 3 months prior to the first dose
7. Having any other diseases or conditions that may affect the normal performance of the study or the evaluation of the study data, or having other conditions that are not suitable for the study, as judged by investigators

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
HMPL-523	150 µCi [14C]HMPL-523	HMPL-523 Tablet 300 mg QD7 days followed by a single oral dose of \[14C\]HMPL-523 suspension
HMPL-523	HMPL-523	HMPL-523 Tablet 300 mg QD7 days followed by a single oral dose of \[14C\]HMPL-523 suspension

Primary Outcome Measures

Name	Time	Method
the Human Mass Balance	Day8	To evaluate the absorption, metabolism and excretion of HMPL-523 in healthy male Chinese subjects followed by a single oral dose of \[14C\]HMPL-523 suspension

Trial Locations

Locations (1)

The First Affiliated Hospital of Soochow University; 🇨🇳 Suzhou, Jiangsu, China