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CompletedNCT03977805Updated May 8, 2020

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

A Phase 1 interventional study of Hetrombopag Olamine in Healthy, sponsored by Jiangsu HengRui Medicine Co., Ltd.. Completed at 1 site in China. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-05-08.

Sponsored by Jiangsu HengRui Medicine Co., Ltd. · Phase 1, Interventional, and Other

Phase
Phase 1
Study type
Interventional
Enrollment
6
Allocation
Not applicable
Ages
18 Years to 45 Years
Sex
Male
01

Study 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).

Read the 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.

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd. is the lead sponsor of 559 studies on the registry; 85 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 1 (11%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
6 participants (actual)

Study arms

  • Experimental
    Hetrombopag Olamine

    Hetrombopag Olamine (5 mg, 100 uCi)

    Drug: Hetrombopag Olamine

Interventions

  • DrugHetrombopag Olamine

    a single oral taking

06

What researchers measure

Primary outcomes

  1. Total radioactivity pharmacokinetics in whole blood and plasma

    plasma concentration of total radioactivity

    Time frame: From 1 hour before administration to 240 hours after administration

  2. total radioactivity in the excreta

    Excretion of radioactivity in human urine and feces

    Time frame: From 24 hour before administration to 336 hours after administration

  3. the concentration of Hetrombopag in plasma

    Area under the plasma concentration versus time curve (AUC)

    Time frame: From 1 hour before administration to 240 hours after administration

  4. individual metabolite profiles in plasma 、urine and faces

    Using quantitative High Performance Liquid Chromatography-Mass Spectroscopic method to analyse individual percentage of metabolites.

    Time frame: From 24 hour before administration to 336 hours after administration

  5. mean metabolite profiles in plasma 、urine and faces

    Using quantitative High Performance Liquid Chromatography-Mass Spectroscopic method to analyse mean percentage of metabolites.

    Time frame: From 24 hour before administration to 336 hours after administration

07

Study locations

1 site
  • The first affiliated hospital of Suzhou university
    Suzhou, Jiangsu, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 8, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03977805
Lead sponsor
Jiangsu HengRui Medicine Co., Ltd.
Responsible party
Sponsor
First posted
Jun 6, 2019
Start date
May 25, 2019
Primary completion
Jun 13, 2019
Completion
Jun 13, 2019
Last update
May 8, 2020

Study contacts

Liyan Miao, PhD
principal investigator · First Affiliated Hospital of Suzhou Medical College

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.

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