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A Study to Evaluate the Pharmacokinetics of HSK7653 in Subjects With Renal Impairment

NCT05497297 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2023-01-03

No results posted yet for this study

Summary

This is an open-label, single-dose study to evaluate the pharmacokinetics, pharmacodynamics and safety of HSK7653 in subjects with mild, moderate, severe renal impairment and subjects with kidney failure compared to the matched control subjects with normal renal function.

Conditions

  • Renal Impairment

Interventions

DRUG

HSK7653 tablets

HSK7653, tablet, oral

Sponsors & Collaborators

  • Haisco Pharmaceutical Group Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Wang Meixia · Beijing Jishuitan Hospital

  • Zhang dongliang · Beijing Jishuitan Hospital

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
2022-08-04
Primary Completion
2022-10-23
Completion
2022-10-26

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 NCT05497297 on ClinicalTrials.gov