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Pharmacokinetics and Safety Study of YZJ-1139 in Subjects With Mild, Moderate and Normal Hepatic Impairment

NCT06671509 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2024-11-04

No results posted yet for this study

Summary

Primary Objectives:

To evaluate the effect of the subjects with mild (Child Pugh A), moderate (Child Pugh B) and normal hepatic impairment on the pharmacokinetics of YZJ-1139

Secondary Objectives:

To evaluate the safety of a single oral dose of YZJ-1139 in subjects with mild, moderate and normal hepatic impairment

Conditions

Interventions

DRUG

YZJ-1139

Single oral dose, 20 mg tablet

Sponsors & Collaborators

  • Shanghai Haiyan Pharmaceutical Technology Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-03-22
Primary Completion
2024-04-18
Completion
2024-08-07

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06671509 on ClinicalTrials.gov