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

Primary Purpose

Imumune Thrombocytopenia(ITP) Human Mass Balance

Status
Active
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
HMPL-523
150 µCi [14C]HMPL-523
Sponsored by
Hutchmed
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Imumune Thrombocytopenia(ITP) Human Mass Balance

Eligibility Criteria

18 Years - 40 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • The First Affiliated Hospital of Soochow University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HMPL-523

Arm Description

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

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Full Information

First Posted
February 7, 2023
Last Updated
July 9, 2023
Sponsor
Hutchmed
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1. Study Identification

Unique Protocol Identification Number
NCT05781906
Brief Title
Human Mass Balance of [14C]HMPL-523 in Healthy Adult Male Chinese Subjects
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 8, 2023 (Actual)
Primary Completion Date
June 1, 2023 (Actual)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hutchmed

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Imumune Thrombocytopenia(ITP) Human Mass Balance

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HMPL-523
Arm Type
Experimental
Arm Description
HMPL-523 Tablet 300 mg QD7 days followed by a single oral dose of [14C]HMPL-523 suspension
Intervention Type
Drug
Intervention Name(s)
HMPL-523
Other Intervention Name(s)
HMPL-523 tablets
Intervention Description
D1-D7: HMPL-523 Tablet 300 mg QD
Intervention Type
Drug
Intervention Name(s)
150 µCi [14C]HMPL-523
Other Intervention Name(s)
150 µCi [14C]HMPL-523 suspension under fed condition
Intervention Description
D8: [14C] HMPL-523 Suspension 300 mg/150 μCi Single dose
Primary Outcome Measure Information:
Title
the Human Mass Balance
Description
To evaluate the absorption, metabolism and excretion of HMPL-523 in healthy male Chinese subjects following multiple oral doses of HMPL-523 tablets
Time Frame
Day1-Day7
Title
the Human Mass Balance
Description
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
Time Frame
Day8

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liyan Miao
Organizational Affiliation
offices director
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital of Soochow University
City
Suzhou
State/Province
Jiangsu
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

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

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