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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Single-center, Open-label, Multi-dose Study to Investigate the Human Mass Balance in Healthy Adult Male Following Multiple Oral Doses of HMPL-523 Tablets Followed by a Single Oral Dose of 300 mg/150 µCi [14C]HMPL-523 Suspension

Conditions
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Imumune Thrombocytopenia(ITP) Human Mass Balance

Intervention / Treatment
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* Drug: HMPL-523
* Drug: 150 µCi [14C]HMPL-523


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects who have voluntarily participated in the study and signed the informed consent form with good compliance; Healthy male subjects aged 18-40 years (inclusive); Subjects weighing ≥ 50 kg Subjects in good health status Exclusion Criteria: 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 hypersensitivity to the investigational product and its excipients Subjects with diseases affecting the absorption, distribution, metabolism and excretion of oral drugs, Subjects with fear of needles, hemophobia, difficulty collecting venous blood, or special requirements for diet, who cannot comply with uniform diet Subjects who are abnormal with clinical significance for C-reactive protein or positive for coronavirus nucleic acid detection in coronavirus infection screening 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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HMPL-523<br>HMPL-523 Tablet 300 mg QD7 days followed by a single oral dose of [14C]HMPL-523 suspension | Drug: HMPL-523<br>* D1-D7: HMPL-523 Tablet 300 mg QD<br>* Other names: HMPL-523 tablets;Drug: 150 µCi [14C]HMPL-523<br>* D8: [14C] HMPL-523 Suspension 300 mg/150 μCi Single dose<br>* Other names: 150 µCi [14C]HMPL-523 suspension under fed condition;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the Human Mass Balance | To evaluate the absorption, metabolism and excretion of HMPL-523 in healthy male Chinese subjects following multiple oral doses of HMPL-523 tablets | Day1-Day7 | 
| the Human Mass Balance | 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 | Day8 |