assessment of the pharmacokinetics and safety of ant3310 combined with meropenem in renally impaired subjects

Conditions: Renal Impairment

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.

the participants will receive 1 single dose of the combination of ant3310 and meropenem (2 times a single dose in participants with esrd).

Eligibility criteria:
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 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). * for participants with impaired renal function: acute renal failure or active renal infections, clinically significant impaired hepatic function, severe infection or any clinically significant illness within 4 weeks before dosing, impairment of any other major organ system other than the kidney except underlying disease, diagnosed malignancy during the past 5 years except completely resected basal cell cancer of the skin, any kidney transplant during the last 10 years, any other organ transplant during the past 5 years.