Clinical trial NCT03977805: Metabolism and Disposition of [14C] Herombopag in Chinese Healthy Human Subjects
Official title: Metabolism and Disposition of [14C] Herombopag in Chinese Healthy Human Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-06-06
Enrollment: 6
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Total radioactivity pharmacokinetics in whole blood and plasma
timeFrame: From 1 hour before administration to 240 hours after administration
measure: total radioactivity in the excreta
timeFrame: From 24 hour before administration to 336 hours after administration
measure: the concentration of Hetrombopag in plasma
timeFrame: From 1 hour before administration to 240 hours after administration
measure: individual metabolite profiles in plasma 、urine and faces
timeFrame: From 24 hour before administration to 336 hours after administration
measure: mean metabolite profiles in plasma 、urine and faces
timeFrame: From 24 hour before administration to 336 hours after administration
Secondary outcomes:
Other outcomes:
Locations:
city: Suzhou
country: China
facility: The first affiliated hospital of Suzhou university
state: Jiangsu
Study officials:
affiliation: First Affiliated Hospital of Suzhou Medical College
name: Liyan Miao, PhD
role: PRINCIPAL_INVESTIGATOR
References: