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Pharmacokinetics Of Jaktinib In Subjects With Hepatic Impairment And Normal Hepatic Function

NCT04993404 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2024-01-11

No results posted yet for this study

Summary

This multi-center, open-label, parallel-controlled, single-dose Phase 1 study is being conducted to directly characterize the pharmacokinetic (PK) profiles and safety of Jaktinib following administration of a single oral dose in subjects with varying degrees of hepatic impairment compared to healthy matched control subjects with normal hepatic function(matched by age, weight, and sex).

Conditions

  • Hepatic Insufficiency
  • Healthy Subjects

Interventions

DRUG

Jaktinib Hydrochloride Tablets

A single oral dose of 100 mg Jaktinib Hydrochloride Tablets will be administered.

Sponsors & Collaborators

  • Suzhou Zelgen Biopharmaceuticals Co.,Ltd

    lead INDUSTRY

Principal Investigators

  • Liyan Miao, PhD · The First Affiliated Hospital of Soochow University

  • Weifeng Zhao, PhD · The First Affiliated Hospital of Soochow University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-08-27
Primary Completion
2022-09-19
Completion
2022-09-19

Countries

  • China

Study Locations

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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 NCT04993404 on ClinicalTrials.gov