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

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Hengrui Medicine

Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

Drug: Hetrombopag Olamine

Study type

Interventional

Funder types

Industry

Identifiers

NCT03977805
HR-TPO-Ih

Details and patient eligibility

About

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).

Full 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.

Enrollment

6 patients

Sex

Male

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

6 participants in 1 patient group

Hetrombopag Olamine
Experimental group
Description:
Hetrombopag Olamine (5 mg, 100 uCi)
Treatment:
Drug: Hetrombopag Olamine

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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