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OpenTrials
Completed

NCT Number: NCT06547502

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

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.

Completed

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Site 1

Suzhou, Jiangsu, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GZR4

Drug

single dose

Primary outcomes

  1. AUC0-inf

    Time frame: Day1-Day29

  2. AUC0-last

    Time frame: Day1-Day29

  3. Cmax

    Time frame: Day1-Day29

Secondary outcomes

  1. Incidence of TEAE

    Time frame: Day1-Day29

  2. AUC0-168h

    Time frame: Day1-Day29

  3. Tmax

    Time frame: Day1-Day29

  4. T1/2

    Time frame: Day1-Day29

Sponsors and collaborators

Lead sponsor

Gan and Lee Pharmaceuticals, USA

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 9, 2024
Registry last updated
Dec 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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