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GP681 in Volunteers With Hepatic Impairment Compared With Healthy Volunteers

NCT05814926 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2023-11-15

No results posted yet for this study

Summary

The primary objective of this study is to test whether mild (Child-Pugh A, score 5-6) and moderate (Child-Pugh B, score 7-9) hepatic impairment affects pharmacokinetics, safety and tolerability of GP681, compared with a control group with normal hepatic function following oral administration of GP681 as single dose.

Conditions

  • Healthy Volunteers
  • Hepatic Impairment

Interventions

DRUG

GP681

GP681, tablet, oral

Sponsors & Collaborators

  • Jiangxi Qingfeng Pharmaceutical Co. Ltd.

    lead INDUSTRY

Principal Investigators

  • Haibin Yu · Beijing YouAn Hospital

  • Bin Xu · Beijing YouAn Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2023-04-26
Primary Completion
2023-08-03
Completion
2023-10-20

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 NCT05814926 on ClinicalTrials.gov