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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Hetrombopag Olamine

• Registration Number: NCT03977805
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2019-05-05
• Study Start: 2019-05-25
• Study First Submitted QC: 2019-06-04
• Study First Posted: 2019-06-06
• Primary Completion: 2019-06-13
• Study Completion: 2019-06-13
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-06
• Last Update Posted: 2020-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 6

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hetrombopag Olamine	Hetrombopag Olamine	Hetrombopag Olamine (5 mg, 100 uCi)

Primary Outcome Measures

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

Trial Locations

Locations (1)

The first affiliated hospital of Suzhou university; 🇨🇳 Suzhou, Jiangsu, China