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

Sponsor
Hutchmed (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05781906
Collaborator
(none)
10
Enrollment
1
Location
1
Arm
9.7
Anticipated Duration (Months)
1
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
Phase 1

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 Design

Study Type:
Interventional
Anticipated Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
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
Actual Study Start Date :
Feb 8, 2023
Anticipated Primary Completion Date :
Apr 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. the Human Mass Balance [Day1-Day7]

      To evaluate the absorption, metabolism and excretion of HMPL-523 in healthy male Chinese subjects following multiple oral doses of HMPL-523 tablets

    2. the Human Mass Balance [Day8]

      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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 40 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The First Affiliated Hospital of Soochow University Suzhou Jiangsu China

    Sponsors and Collaborators

    • Hutchmed

    Investigators

    • Principal Investigator: Liyan Miao, offices director

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hutchmed
    ClinicalTrials.gov Identifier:
    NCT05781906
    Other Study ID Numbers:
    • 2022-523-00CH3
    First Posted:
    Mar 23, 2023
    Last Update Posted:
    Mar 23, 2023
    Last Verified:
    Mar 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Thrombocytopenia

    Study Results

    No Results Posted as of Mar 23, 2023