Metabolism and Disposition of [14C] Herombopag in Chinese Healthy Human Subjects

Study Overview
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Brief Summary
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This study is a single-center, open-label, single-dose design. It is planning to enroll six Chinese healthy adult male subjects. The metabolism and disposition of Herombopag, will be studied in these subjects after a single oral administration of a solution dose of [14C] Herombopag (5 mg, 100 uCi).

Detailed Description
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The metabolism and disposition of Herombopag, will be studied in six healthy men after a single oral administration of a solution dose of [14C]eltrombopag (5 mg,100 uCi). The sutdy will investigate total radioactivity pharmacokinetics in whole blood and plasma 、quantitatively analyze the the total radioactivity in the excreta、evaluate the predominant route of elimination and indentify the Metabolite profiles in plasma 、urine and faces.

Official Title
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Metabolism and Disposition of [14C] Herombopag in Chinese Healthy Human Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: Hetrombopag Olamine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Health male subjects, age between 18-45 years. BMI between 19 and 26 kg/m2 . Signed informed consent. Exclusion Criteria: Abnormal results in physical examination、laboratory tests、X-ray、abdominal ultrasound、echocardiography have clinical significance. Abnormal platelet counts or platelet aggregation has clinical significance. Abnormal troponin examination has clinical significance. Abnormal ophthalmic examination has clinical significance. Hepatitis B surface antigen, hepatitis C antibody, syphilis antibody or HIV antibody is positive. Those who have a history of allergies to test drugs or similar drugs. Those who have undergone surgery within 6 months prior to the trial . Those who took any drug within 14 days before the test (including Chinese herbal medicine). Any drug that inhibits or induces liver drug metabolism within 30 days before the test. Subjects who have participated in other clinical trial within the 3 months prior to study entry. One or more non-pharmacological contraceptive measures cannot be used during the trial or it is planned to have birth within one year.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hetrombopag Olamine<br>Hetrombopag Olamine (5 mg, 100 uCi) | Drug: Hetrombopag Olamine<br>* a single oral taking<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total radioactivity pharmacokinetics in whole blood and plasma | plasma concentration of total radioactivity | From 1 hour before administration to 240 hours after administration | 
| total radioactivity in the excreta | Excretion of radioactivity in human urine and feces | From 24 hour before administration to 336 hours after administration | 
| the concentration of Hetrombopag in plasma | Area under the plasma concentration versus time curve (AUC) | From 1 hour before administration to 240 hours after administration | 
| individual metabolite profiles in plasma 、urine and faces | Using quantitative High Performance Liquid Chromatography-Mass Spectroscopic method to analyse individual percentage of metabolites. | From 24 hour before administration to 336 hours after administration | 
| mean metabolite profiles in plasma 、urine and faces | Using quantitative High Performance Liquid Chromatography-Mass Spectroscopic method to analyse mean percentage of metabolites. | From 24 hour before administration to 336 hours after administration |