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

Gan and Lee Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Diabetes

Treatments: Drug: GZR4

Study type: Interventional

Funder types: Industry

Identifiers

NCT06547502

GZR4-T2D-104

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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16 participants in 3 patient groups

Normal renal function

Experimental group

Description:

GFR between 90-130 ml/min

Treatment:

Drug: GZR4

Mildly decreased renal function

Experimental group

Description:

GFR between 60-90 ml/min

Treatment:

Drug: GZR4

moderately decreased renal function

Experimental group

Description:

GFR between 30-60 ml/min

Treatment:

Drug: GZR4