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

NCT ID: NCT06547502

Last Updated: 2024-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-03

Study Completion Date

2024-09-05

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes

Keywords

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GZR4 kidney

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Normal renal function

GFR between 90-130 ml/min

Group Type EXPERIMENTAL

GZR4

Intervention Type DRUG

single dose

Mildly decreased renal function

GFR between 60-90 ml/min

Group Type EXPERIMENTAL

GZR4

Intervention Type DRUG

single dose

moderately decreased renal function

GFR between 30-60 ml/min

Group Type EXPERIMENTAL

GZR4

Intervention Type DRUG

single dose

Interventions

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GZR4

single dose

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Gan and Lee Pharmaceuticals, USA

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Site 1

Suzhou, Jiangsu, China

Site Status

Countries

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China

Other Identifiers

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GZR4-T2D-104

Identifier Type: -

Identifier Source: org_study_id