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

NCT05781906 | Completed Phase 1 DMC

• 1 other identifier: 2022-523-00CH3
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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

Conditions

Imumune Thrombocytopenia(ITP) Human Mass Balance

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

HMPL-523

EXPERIMENTAL

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

Drug: HMPL-523; Drug: 150 µCi [14C]HMPL-523

Interventions

HMPL-523 DRUG

D1-D7: HMPL-523 Tablet 300 mg QD

Also known as: HMPL-523 tablets

HMPL-523

150 µCi [14C]HMPL-523 DRUG

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

Also known as: 150 µCi [14C]HMPL-523 suspension under fed condition

HMPL-523

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hutchmed: lead

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Location

Study Officials

• Liyan Miao

  offices director

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2023
• First Posted: March 23, 2023
• Study Start: February 8, 2023
• Primary Completion: June 1, 2023
• Study Completion: December 6, 2023
• Last Updated: July 16, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR

Locations

CN (1)