NCT05088642

A Trial of Hetrombopag in Healthy and Hepatic Impairment Subjects

A Phase I Clinical Study Evaluating the Pharmacokinetics and Safety of Hetrombopag Olamine Tablets in Subjects With Mild Hepatic Impairment (Child-Pugh Class A), Moderate Hepatic Impairment (Child-Pugh Class B), and Normal Hepatic Function

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a single-dose, open-label, phase I clinical study evaluating the PK of hetrombopag in subjects with mild hepatic impairment (Child-Pugh Class A), subjects with moderate hepatic impairment (Child-Pugh Class B), as well as age-, weight-, and gender-matched subjects with normal hepatic function.

Conditions

• Sever Aplastic Anaemia

Interventions

Type	Name	Description
DRUG	Hetrombopag Olamine Tablet	Hetrombopag Olamine Tablet

Timeline

• Start date: 2020-09-28
• Primary completion: 2020-12-04
• Completion: 2020-12-04
• First posted: 2021-10-22
• Last updated: 2021-10-22

Locations

1 site across 1 country: China