Assessment of the Pharmacokinetics and Safety of ANT3310 Combined With Meropenem in Renally Impaired Subjects
NCT Number: NCT06527677
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Renal Impairment
Interventions: DRUG: ANT3310|DRUG: Meropenem
Sponsor: Antabio
Collaborators: Clinical Research Center Kiel GmbH
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 48
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-07-19
Completion Date: 2025-08
Locations: CRS Clinical Research Services Kiel GmbH, Kiel, D-24105, Germany

Summary:
This is an open-label, non-randomized, single-center, single i.v. dose Phase 1 trial to evaluate the pharmacokinetics and safety of a combination of ANT3310 and meropenem in participants with different degrees of renal function impairment, including participants with End-Stage Renal Disease (ESRD), compared with matching control participants with normal renal function.

Primary Outcome Measures: Maximum Plasma Concentrations (Cmax) of ANT3310 and Meropenem after a single i.v. infusion of the combination ANT3310-Meropenem, Pharmacokinetic parameter of ANT3310 and Meropenem in plasma., From pre-dose to Day 3|Area under the curve from 0 to infinity (AUC0-inf) of ANT3310 and Meropenem after a single i.v. infusion of the combination ANT3310-Meropenem, Pharmacokinetic parameter of ANT3310 and Meropenem in plasma., From pre-dose to Day 3|Time from dosing to maximum observed concentration (tmax) of ANT3310 and Meropenem after a single i.v. infusion of the combination ANT3310-Meropenem, Pharmacokinetic parameter of ANT3310 and Meropenem in plasma., From pre-dose to Day 3|Apparent terminal elimination half-life (t1/2λz) of ANT3310 and Meropenem after a single i.v. infusion of the combination ANT3310-Meropenem, Pharmacokinetic parameter of ANT3310 and Meropenem in plasma., From pre-dose to Day 3|Area under the curve from time 0 to time of last measurable concentration (AUC0-last) of ANT3310 and Meropenem after a single i.v. infusion of the combination ANT3310-Meropenem, Pharmacokinetic parameter of ANT3310 and Meropenem in plasma., From pre-dose to Day 3|Area under the curve from time 0 to 48h (AUC0-48h) of ANT3310 and Meropenem after a single i.v. infusion of the combination ANT3310-Meropenem, Pharmacokinetic parameter of ANT3310 and Meropenem in plasma., From pre-dose to Day 3|Percentage of AUC0-inf obtained by extrapolation (AUCext) of ANT3310 and Meropenem after a single i.v. infusion of the combination ANT3310-Meropenem, Pharmacokinetic parameter of ANT3310 and Meropenem in plasma., From pre-dose to Day 3|Total body clearance (CL) of ANT3310 and Meropenem after a single i.v. infusion of the combination ANT3310-Meropenem, Pharmacokinetic parameter of ANT3310 and Meropenem in plasma., From pre-dose to Day 3|Non-renal clearance (CLNonR) of ANT3310 and Meropenem after a single i.v. infusion of the combination ANT3310-Meropenem, Pharmacokinetic parameter of ANT3310 and Meropenem in plasma and urine., From pre-dose to Day 3|Apparent volume of distribution during the terminal phase after administration (Vz) of ANT3310 and Meropenem after a single i.v. infusion of the combination ANT3310-Meropenem, Pharmacokinetic parameter of ANT3310 and Meropenem in plasma., From pre-dose to Day 3|Mean residence time (MRT) of ANT3310 and Meropenem after a single i.v. infusion of the combination ANT3310-Meropenem, Pharmacokinetic parameter of ANT3310 and Meropenem in plasma., From pre-dose to Day 3|Amount of ANT3310 and Meropenem that is eliminated in urine from 0 to infinity (Ae0-inf) after a single i.v. infusion of the combination ANT3310-Meropenem, Pharmacokinetic parameter of ANT3310 and Meropenem in urine., From pre-dose to Day 3|Renal clearance (CLR) of ANT3310 and Meropenem after a single i.v. infusion of the combination ANT3310-Meropenem, Pharmacokinetic parameter of ANT3310 and Meropenem in urine., From pre-dose to Day 3|Fraction of dose recovered in urine (fe) of ANT3310 and Meropenem after a single i.v. infusion of the combination ANT3310-Meropenem, Pharmacokinetic parameter of ANT3310 and Meropenem in urine., From pre-dose to Day 3|Amount of ANT3310 and Meropenem that is eliminated in urine from 0 to 48h (Ae0-48h) after a single i.v. infusion of the combination ANT3310-Meropenem, Pharmacokinetic parameter of ANT3310 and Meropenem in urine., From pre-dose to Day 3|Fraction of dose recovered in urine from 0 to 48 hours (fe0-48h) of ANT3310 and Meropenem after a single i.v. infusion of the combination ANT3310-Meropenem, Pharmacokinetic parameter of ANT3310 and Meropenem in urine., From pre-dose to Day 3|Renal clearance from 0 to 48 hours (CLR[0-48h]) of ANT3310 and Meropenem after a single i.v. infusion of the combination ANT3310-Meropenem, Pharmacokinetic parameter of ANT3310 and Meropenem in urine., From pre-dose to Day 3|Dialysis clearance (CLD) of ANT3310 and Meropenem after a single i.v. infusion of the combination ANT3310-Meropenem in dialysed subjects, Pharmacokinetic parameter of ANT3310 and Meropenem in dialysate and plasma., during dialysis
Secondary Outcome Measures: Number and severity of treatment-emergent adverse event (TEAE) to evaluate the safety and tolerability of ANT3310 and meropenem after a single i.v. infusion of a combination of ANT3310 and meropenem., Percentage of participants experiencing ≥ one treatment-emergent adverse event (TEAE) by seriousness, intensity, and relatedness from baseline to end of study (EoS) or early withdrawal., 0 hours to Day 9|Number of participants who discontinue due to a TEAE., Percentage of participants who discontinue due to a TEAE., 0 hours to Day 9|Number of participants who meet the clinically significant abnormal criteria for safety laboratory tests at least once after start of dosing., Percentage of participants who meet the clinically significant abnormal criteria for safety laboratory tests at least once after start of dosing., 0 hours to Day 9|Number of participants meeting the clinically significant abnormal criteria for vital signs measurements at least once after start of dosing., Percentage of participants meeting the clinically significant abnormal criteria for vital signs (blood pressure, pulse rate, respiratory rate, and body temperature) measurements at least once after start of dosing., 0 hours to Day 9|Number of participants who meet the clinically significant abnormal criteria for ECG (Electrocardiogram) parameters., Percentage of participants who meet the clinically significant abnormal criteria for ECG parameters., Day-1 to Day 9|Number of infusion site reactions to assess local venous tolerability, From pre-dose on Day 1 to Day 3