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Study to Evaluate Orelabrutinib Tablets in Subjects With Hepatic Impairment and Healthy Subject

NCT05684653 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2023-09-21

No results posted yet for this study

Summary

This is an Open-Label, Parallel, Single-dose, Phase I Clinical Study to Evaluate the Pharmacokinetics and Safety of Orelabrutinib Tablets in Subjects with Varying Degrees of Hepatic Impairment

Conditions

  • Hepatic Impairment

Interventions

DRUG

Orelabrutinib Tablets

50 mg, single oral dose

Sponsors & Collaborators

  • Beijing InnoCare Pharma Tech Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2023-03-17
Primary Completion
2023-12-30
Completion
2023-12-30

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 NCT05684653 on ClinicalTrials.gov