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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.
Study of pharmacokinetics and safety of apraglutide in participants with normal and impaired kidney function.
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.
Age
18 - 75 years
Sex
ALL
Healthy Volunteers
Yes
Orlando Clinical Research Center
Orlando, Florida, United States
Prism Clinical Research, Inc.
Saint Paul, Minnesota, United States
Start Date
December 8, 2020
Primary Completion Date
July 5, 2021
Completion Date
July 5, 2021
Last Updated
October 26, 2024
16
ACTUAL participants
Apraglutide
DRUG
Lead Sponsor
VectivBio AG
NCT07241390
NCT06926660
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT06717698