Pharmacokinetics and Safety Profile of a Single Dose GZR4 in Subjects with Renal Impairment

December 4, 2024 updated by: Gan and Lee Pharmaceuticals, USA

The Study of Pharmacokinetics and Safety of a Single Dose of GZR4 Injection in Subjects with Mild to Moderate Renal Impairment and Subjects with Normal Renal Function

This study will be conducted to investigated the effect of decreased kidney function on PK and safety of GZR4 and to guide dosing recommendations in people with kidney impairment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Suzhou, Jiangsu, China
        • Site 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Male or female, aged 18-75 years (both inclusive) at the time of signing informed consent
  • Meeting the pre-defined Glomerular Filtration Rate (GFR) values

Exclusion Criteria:

  • Known or suspected hypersensitivity to trial product
  • Drugs known to affect creatinine clearance including cimetidine within 14 days or 5 half-lives prior to the day of dosing of GZR4 and during this trial
  • Individuals who routinely undergo dialysis or have a history of renal transplantation, hepatorenal syndrome, or acute kidney injury

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Normal renal function
GFR between 90-130 ml/min
Drug: GZR4
single dose
Experimental: Mildly decreased renal function
GFR between 60-90 ml/min
Drug: GZR4
single dose
Experimental: moderately decreased renal function
GFR between 30-60 ml/min
Drug: GZR4
single dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
AUC0-inf
Time Frame: Day1-Day29
Day1-Day29
AUC0-last
Time Frame: Day1-Day29
Day1-Day29
Cmax
Time Frame: Day1-Day29
Day1-Day29

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of TEAE
Time Frame: Day1-Day29
Day1-Day29
AUC0-168h
Time Frame: Day1-Day29
Day1-Day29
Tmax
Time Frame: Day1-Day29
Day1-Day29
T1/2
Time Frame: Day1-Day29
Day1-Day29

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gan and Lee Pharmaceuticals, USA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 3, 2024

Primary Completion (Actual)

August 20, 2024

Study Completion (Actual)

September 5, 2024

Study Registration Dates

First Submitted

August 7, 2024

First Submitted That Met QC Criteria

August 8, 2024

First Posted (Actual)

August 9, 2024

Study Record Updates

Last Update Posted (Estimated)

December 9, 2024

Last Update Submitted That Met QC Criteria

December 4, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GZR4-T2D-104

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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