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

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).

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Hetrombopag Olamine

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 Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Suzhou, Jiangsu, China
      • The first affiliated hospital of suzhou University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hetrombopag Olamine; Hetrombopag Olamine (5 mg, 100 uCi)	Drug: Hetrombopag Olamine; a single oral taking

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2019
• Primary Completion (Actual): June 13, 2019
• Study Completion (Actual): June 13, 2019

Study Registration Dates

• First Submitted: May 5, 2019
• First Submitted That Met QC Criteria: June 4, 2019
• First Posted (Actual): June 6, 2019

Study Record Updates

• Last Update Posted (Actual): May 8, 2020
• Last Update Submitted That Met QC Criteria: May 6, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: HR-TPO-Ih

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No