NCT04699032

Study of Pharmacokinetics and Safety of Apraglutide in Participants With Normal and Impaired Kidney Function.

A Phase 1, Open-Label Evaluation of the Pharmacokinetics and Safety of a Single Dose of Apraglutide in Subjects With Normal and Impaired Renal Function.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: VectivBio AG · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

Study of pharmacokinetics and safety of apraglutide in participants with normal and impaired kidney function.

Detailed 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 was 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). Enrollment into Part 2 was conditional on the results of Part 1.

Conditions

• Chronic Kidney Disease

Interventions

Type	Name	Description
DRUG	Apraglutide	Single dose of apraglutide 5 mg.

Timeline

• Start date: 2020-12-08
• Primary completion: 2021-07-05
• Completion: 2021-07-05
• First posted: 2021-01-07
• Last updated: 2024-10-26
• Results posted: 2023-05-15

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study