Study of Pharmacokinetics and Safety of Apraglutide in Participants With Normal and Impaired Kidney Function.
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Chronic Kidney Disease
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: Non-RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 75 years
- Gender
- Both males and females
Description
A two stage design, open label, multi-center, non-randomized trial to evaluate the PK and safety of a single subcutaneous dose of 5 mg apraglutide in subjects with varying degrees of renal function. The renal function will be calculated by the estimated glomerular filtration rate (eGFR) according to...
A two stage design, open label, multi-center, non-randomized trial to evaluate the PK and safety of a single subcutaneous dose of 5 mg apraglutide in subjects with varying degrees of renal function. The renal function will be calculated by the estimated glomerular filtration rate (eGFR) according to the Chronic Kidney Disease Epidemiology (CKD-EPI) Creatinine Equation. Part 1: 8 subjects with severe renal impairment (Cohort 1) and 8 subjects with normal renal function (Cohort 2). Part 2: 8 subjects with moderate (Cohort 3) and 8 subjects with mild (Cohort 4). Part 2 will be conducted if the geometric mean ratio (GMR) of AUC-inf or AUC_last for the severe renal impairment group compared to the control group is ?2.
Tracking Information
- NCT #
- NCT04699032
- Collaborators
- Not Provided
- Investigators
- Study Director: Greig VectivBio AG
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