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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-25

Study Completion Date

2019-06-13

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Relative Bioavailability of Early Phase and Late Phase Hetrombopag Olamine Formulations

NCT04688008

Bioavailability Study

COMPLETED PHASE1

Excretion Balance, Pharmacokinetics, and Metabolism Following of [14C]-Venglustat Administration in Healthy Male Subjects

NCT05238714

Disorders of Sphingolipid Metabolism Healthy Volunteers

COMPLETED PHASE1

Study to Assess Pharmacokinetics, Safety, and Tolerability of MT-7117 in Subjects With Normal and Impaired Hepatic Function

NCT04116476

Mild and Moderate Hepatic Impairment

COMPLETED PHASE1

A Single Center, Open-Label Study to Quantify Metabolites of [14C]-Neramexane in Plasma and Urine in Healthy Male Subjects

NCT01109680

Metabolism of Neramexane

COMPLETED PHASE1

Pharmacokinetic and Metabolism of [14^C] BMS-986177 in Healthy Male Participants

NCT03939702

Thrombosis

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Hetrombopag Olamine

Hetrombopag Olamine (5 mg, 100 uCi)

Group Type EXPERIMENTAL

Hetrombopag Olamine

Intervention Type DRUG

a single oral taking

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Hetrombopag Olamine

a single oral taking

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes