Status:
COMPLETED
Pharmacokinetics and Safety Profile of a Single Dose GZR4 in Subjects with Renal Impairment
Lead Sponsor:
Gan and Lee Pharmaceuticals, USA
Conditions:
Diabetes
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 3 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 5 2024
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT06547502
Start Date
July 3 2024
End Date
September 5 2024
Last Update
December 9 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Site 1
Suzhou, Jiangsu, China