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

NCT ID: NCT05781906

Last Updated: 2024-07-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-08
• Study Completion Date: 2023-12-06

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.

Conditions

Imumune Thrombocytopenia(ITP) Human Mass Balance

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

HMPL-523

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

Group Type: EXPERIMENTAL

HMPL-523

Intervention Type: DRUG

D1-D7: HMPL-523 Tablet 300 mg QD

150 µCi [14C]HMPL-523

Intervention Type: DRUG

D8: \[14C\] HMPL-523 Suspension 300 mg/150 μCi Single dose

Interventions

HMPL-523

D1-D7: HMPL-523 Tablet 300 mg QD

Intervention Type: DRUG

150 µCi [14C]HMPL-523

D8: \[14C\] HMPL-523 Suspension 300 mg/150 μCi Single dose

Intervention Type: DRUG

Other Intervention Names

HMPL-523 tablets; 150 µCi [14C]HMPL-523 suspension under fed condition

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Hutchmed

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Liyan Miao

Role: PRINCIPAL_INVESTIGATOR

offices director

Locations

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Countries

China

Other Identifiers

2022-523-00CH3

Identifier Type: -

Identifier Source: org_study_id