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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Single dose of apraglutide 5 mg.
Orlando Clinical Research Center
Orlando, Florida, United States
Prism Clinical Research, Inc.
Saint Paul, Minnesota, United States
Maximum Plasma Concentration (Cmax) of Apraglutide
Pharmacokinetic (PK) samples collected for the measurement of plasma concentration of apraglutide were analyzed using a validated analytical method in compliance with applicable standard operating procedures.
Time frame: 5 minutes pre-dose up to 240 hours after dosing on Day 1
Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) of Apraglutide
PK samples collected for the measurement of plasma concentration of apraglutide were analyzed using a validated analytical method in compliance with applicable standard operating procedures.
Time frame: 5 minutes pre-dose up to 240 hours after dosing on Day 1
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
TEAEs were defined as adverse events (AEs) that occurred after dosing the participant with the study drug. Participants with more than one TEAE were counted only once using the most severe event. Vital signs, triplicate 12-lead electrocardiograms, or clinical laboratory assessments considered clinically significant by the Investigator were reported as AEs.
Time frame: Day 1 up to Day 14
Number of TEAEs
The Investigator used the adjectives mild, moderate, or severe to describe the maximum intensity of the AE. These were defined as follows: * Mild: did not interfere with participant's usual function * Moderate: interfered to some extent with participant's usual function * Severe: interfered significantly with participant's usual function. The Investigator systematically assessed the causal relationship of AEs to IMP/trial treatment using the definitions below: * Not related: Not reasonably related to the IMP. The AE could not medically (pharmacologically/clinically) be attributed to the IMP * Related: Reasonably related to the IMP. The AE could medically (pharmacologically/clinically) be attributed to the IMP. A serious AE (SAE) was classified as any AE that: * Resulted in death * Was life-threatening * Required or prolonged in-patient hospitalization * Resulted in persistent or significant disability/incapacity * Was a congenital anomaly/birth defect in a neo
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Time frame: Day 1 up to Day 14