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

Phase 1

Completed

• Conditions: Diabetes
• Interventions: Drug: GZR4

• Registration Number: NCT06547502
• Lead Sponsor: Gan and Lee Pharmaceuticals, USA

Brief Summary

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

Not available

Study Timeline

• Study Start: 2024-07-03
• Study First Submitted: 2024-08-07
• Study First Submitted QC: 2024-08-08
• Study First Posted: 2024-08-09
• Primary Completion: 2024-08-20
• Study Completion: 2024-09-05
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal renal function	GZR4	GFR between 90-130 ml/min
Mildly decreased renal function	GZR4	GFR between 60-90 ml/min
moderately decreased renal function	GZR4	GFR between 30-60 ml/min

Primary Outcome Measures

Name	Time	Method
Cmax	Day1-Day29
AUC0-inf	Day1-Day29
AUC0-last	Day1-Day29

Secondary Outcome Measures

Name	Time	Method
Incidence of TEAE	Day1-Day29
T1/2	Day1-Day29
AUC0-168h	Day1-Day29
Tmax	Day1-Day29

Trial Locations

Locations (1)

Site 1; 🇨🇳 Suzhou, Jiangsu, China