NCT05781906

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Hutchmed · Industry
• Sex: Male
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

Conditions

• Imumune Thrombocytopenia(ITP) Human Mass Balance

Interventions

Type	Name	Description
DRUG	HMPL-523	D1-D7: HMPL-523 Tablet 300 mg QD
DRUG	150 µCi [14C]HMPL-523	D8: \[14C\] HMPL-523 Suspension 300 mg/150 μCi Single dose

Timeline

• Start date: 2023-02-08
• Primary completion: 2023-06-01
• Completion: 2023-12-06
• First posted: 2023-03-23
• Last updated: 2024-07-16

Locations

1 site across 1 country: China