Imumune Thrombocytopenia(ITP) Human Mass Balance
Conditions
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.
Interventions
DRUGHMPL-523
D1-D7: HMPL-523 Tablet 300 mg QD
DRUG150 µCi [14C]HMPL-523
D8: \[14C\] HMPL-523 Suspension 300 mg/150 μCi Single dose
Sponsors
Hutchmed
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 40 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Outcome results
None listed