Phase 1, Open-Label, Non-Randomized, Single-Center, Single-Dose Study to Assess the Pharmacokinetics & Safety of ANT3310 Combined With Meropenem Administered as a Single Intravenous Infusion to Adult Subjects With Renal Function Impairment

Antabio1 site in 1 country41 target enrollmentJuly 19, 2024

ConditionsRenal Impairment

InterventionsANT3310 Meropenem

DrugsANT3310 Meropenem

Overview

Phase: Phase 1
Intervention: ANT3310
Conditions: Renal Impairment
Sponsor: Antabio
Enrollment: 41
Locations: 1
Primary Endpoint: 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
Status: Completed
Last Updated: 9 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Detailed Description

The participants will receive 1 single dose of the combination of ANT3310 and meropenem (2 times a single dose in participants with ESRD).

Registry

clinicaltrials.gov

Start Date

July 19, 2024

End Date

July 10, 2025

Last Updated

9 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Antabio

Responsible Party

Sponsor

Eligibility Criteria

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.

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 corticosteroids during any time of the year or history of any anaphylactic reaction.
•Medical disorder, condition, or history of such that would - in the opinion of the investigator - compromise the participant's ability to participate in this study.
•History of epilepsy (or known seizure disorder), brain lesions or other significant neurological disorders.
•Known history of clinically significant hypersensitivity or urticaria, or severe allergic reaction to β-lactam antibiotics (e.g., penicillin, cephalosporin, carbapenem, or monobactam).
•History of Gilbert syndrome.
•History of any severe antibiotic-associated superinfections like Clostridium difficile colitis and/or frequent fungal vaginal infections.
•Therapies (e.g., physiotherapy, acupuncture, etc.) within 1 week before study drug administration.
•Positive results for HBsAg, anti-HCV, HIV antibodies (anti-HIV 1+2).

Arms & Interventions

ANT3310 and Meropenem

Participants with mild, moderate, or severe renal function impairment (Panel A, B, and D) and participants with normal renal function (Panel C and F) will receive 1 single dose of a combination of ANT3310 and meropenem. Participants with End Stage Renal Disease (Panel E) will receive 2 times a single dose of a combination of ANT3310 and meropenem: one single dose during dialysis-free interval ("off- dialysis") and one single dose on the day of dialysis ("on-dialysis"). The same dose will be given in both periods with a washout interval of at least 7 days between administrations.

Intervention: ANT3310

ANT3310 and Meropenem

Intervention: Meropenem

Outcomes

Primary Outcomes

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