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NCT Number: NCT03977805

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).

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Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

The first affiliated hospital of Suzhou university

Suzhou, Jiangsu, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hetrombopag Olamine

Drug

a single oral taking

Primary outcomes

  1. Total radioactivity pharmacokinetics in whole blood and plasma

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

    plasma concentration of total radioactivity

  2. total radioactivity in the excreta

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

    Excretion of radioactivity in human urine and feces

  3. the concentration of Hetrombopag in plasma

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

    Area under the plasma concentration versus time curve (AUC)

  4. individual metabolite profiles in plasma 、urine and faces

    Time frame: 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.

  5. mean metabolite profiles in plasma 、urine and faces

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jun 6, 2019
Registry last updated
May 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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