Pharmacokinetics and Safety Profile of a Single Dose GZR4 in Subjects with Renal Impairment
- 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
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 AUC0-inf Day1-Day29 AUC0-last Day1-Day29 Cmax Day1-Day29
- Secondary Outcome Measures
Name Time Method T1/2 Day1-Day29 Incidence of TEAE Day1-Day29 AUC0-168h Day1-Day29 Tmax Day1-Day29
Trial Locations
- Locations (1)
Site 1
🇨🇳Suzhou, Jiangsu, China