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

NCT03977805 | Completed Phase 1

• 1 other identifier: HR-TPO-Ih
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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).

Conditions

Healthy

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (1)

Hetrombopag Olamine

EXPERIMENTAL

Hetrombopag Olamine (5 mg, 100 uCi)

Drug: Hetrombopag Olamine

Interventions

Hetrombopag Olamine DRUG

a single oral taking

Hetrombopag Olamine

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Health male subjects, age between 18-45 years.
• BMI between 19 and 26 kg/m2 .
• Signed informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

The first affiliated hospital of Suzhou university

Suzhou, Jiangsu, China

Location

Study Officials

• Liyan Miao, PhD

  First Affiliated Hospital of Suzhou Medical College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2019
• First Posted: June 6, 2019
• Study Start: May 25, 2019
• Primary Completion: June 13, 2019
• Study Completion: June 13, 2019
• Last Updated: May 8, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)