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A Study to Evaluate the Pharmacokinetics and Safety of DBPR108 in Subjects With Hepatic Impairment

NCT04859426 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2023-04-12

No results posted yet for this study

Summary

This is an open-label, single-dose study to evaluate the pharmacokinetics and safety of DBPR108 in subjects with mild or moderate hepatic impairment (HI) compared to the matched control subjects with normal hepatic function.

Conditions

  • Hepatic Impairment

Interventions

DRUG

DBPR108 tablets

Drug: DBPR108, tablet, oral

Sponsors & Collaborators

  • CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

    lead INDUSTRY

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
2021-06-09
Primary Completion
2022-05-14
Completion
2022-05-17

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 NCT04859426 on ClinicalTrials.gov