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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Imumune Thrombocytopenia(ITP) Human Mass Balance
• Intervention / Treatment: Drug: HMPL-523; Drug: 150 µCi [14C]HMPL-523

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 Type: Interventional
• Enrollment (Estimated): 10
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Angela Niu; Phone Number: 86 18801196102; Email: angelan@hutch-med.com

Study Locations

• China
  • Jiangsu
    • Suzhou, Jiangsu, China
      • The First Affiliated Hospital of Soochow University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hutchmed
• Investigators: Principal Investigator: Liyan Miao, offices director

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2023
• Primary Completion (Actual): June 1, 2023
• Study Completion (Estimated): December 1, 2023

Study Registration Dates

• First Submitted: February 7, 2023
• First Submitted That Met QC Criteria: March 12, 2023
• First Posted (Actual): March 23, 2023

Study Record Updates

• Last Update Posted (Actual): July 11, 2023
• Last Update Submitted That Met QC Criteria: July 9, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Blood Platelet Disorders; Thrombocytopenia
• Other Study ID Numbers: 2022-523-00CH3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No