CompletedPhase 1

Assessment of the Pharmacokinetics and Safety of ANT3310 Combined With Meropenem in Renally Impaired Subjects

Germany41 participantsStarted 2024-07-19

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Main Inclusion Criteria: * Participant must be 18 to 80 years of age (both inclusive) at the time of signing the informed consent. * BMI within the range of 18.0 to 36.0 kg/m2 (both inclusive) with a body weight ≥ 50 kg. * Contraceptive use by women or men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. * Capable of giving signed informed consent in compliance with the requirements and restrictions listed in the ICF and in the protocol. * Ability to cooperate with the investigator and to comply with the requirements of the trial. * Sufficient venous access for i.v. infusion and PK samplings. * For participants with renal function impairment: Individualized eGFR \<90 mL/min at screening, estimated according to the individualized CKD-EPI equation and stable renal function. * For participants with ESRD requiring dialysis: Chronic intermittent hemodialysis for ≥3 months prior to dosing. * For participants with normal renal function: Individualized eGFR ≥90 mL/min at screening, estimated based on serum creatinine measured within 10 days prior to Day -1 according to the CKD-EPI equation. Main Exclusion Criteria: * Febrile illness within 1 week before admission to the study center. * Known hypersensitivity to meropenem and or ANT3310 or any of the excipients of the infusion solution. * Known severe allergies, non-allergic drug reactions, or multiple drug allergies requiring intranasal or systemic cort…

What they're measuring

Maximum Plasma Concentrations (Cmax) of ANT3310 and Meropenem after a single i.v. infusion of the combination ANT3310-Meropenem

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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

Trial details

NCT IDNCT06527677

SponsorAntabio

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-07-03

View on ClinicalTrials.gov More Renal Impairment trials

Plain-language summary

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Maximum Plasma Concentrations (Cmax) of ANT3310 and Meropenem after a single i.v. infusion of the combination ANT3310-Meropenem

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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