Safety and pharmacokinetics of single and multiple ascending doses of avibactam alone and in combination with ceftazidime in healthy male volunteers: results of two randomized, placebo-controlled studies.

Avibactam is a novel non-β-lactam β-lactamase inhibitor effective against Ambler class A, C and some class D β-lactamases that is currently in clinical development in combination with ceftazidime for the treatment of serious Gram-negative infections. It restores the in vitro activity of a range of β-lactams, including ceftazidime, against extended-spectrum β-lactamase-producing pathogens. Two phase I […]

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Effect of age and sex on the pharmacokinetics and safety of avibactam in healthy volunteers

Avibactam is a novel non-β-lactam β-lactamase inhibitor currently being assessed in combination with ceftazidime, ceftaroline fosamil, and aztreonam. The objectives of this study were to investigate the pharmacokinetics, safety, and tolerability of avibactam in healthy young (aged 18-45 years) and elderly (aged ≥65 years) volunteers of both sexes. This was a Phase I, open-label study […]

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Phase 1 Study Assessing the Pharmacokinetic Profile and Safety of Avibactam in Patients with Renal Impairment.

Avibactam is a non-β-lactam β-lactamase inhibitor intended for use as a fixed-dose combination with ceftazidime for the treatment of certain serious Gram-negative infections. As avibactam is primarily excreted unchanged in the urine, renal impairment may affect its pharmacokinetics. This Phase 1 study investigated the effect of renal impairment and hemodialysis on avibactam pharmacokinetics and safety. […]

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Activities of ceftazidime and avibactam against β-lactamase-producing enterobacteriaceae in a hollow-fiber pharmacodynamic model

Avibactam is a novel non-β-lactam β-lactamase inhibitor that is currently undergoing phase 3 clinical trials in combination with ceftazidime. Ceftazidime is hydrolyzed by a broad range of β-lactamases, but avibactam is able to inhibit the majority of these enzymes. The studies described here attempt to provide insight into the amount of avibactam required to suppress […]

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Bacteria Wars: Assessing Drug Safety & PK of Avibactam/Ceftazidime

Henri Merdjan

If the development of antibiotics gave us “A New Hope,” then with the emergence of antibiotic resistance, we are seeing “The Empire [of Pathogenic Bacteria] Strikes Back.” Fortunately, with the development of new drugs such as avibactam, a novel non-β-lactam β-lactamase inhibitor, we may be on the verge of the “Return of Antibiotic Efficacy.” Indeed, the FDA recently approved the combination of avibactam and the previously approved β-lactam antibiotic, ceftazidime, to treat adults with complicated intra-abdominal infections (cIAI), in combination with metronidazole, and complicated urinary tract infections (cUTI), including kidney infections (pyelonephritis), which have limited or no alternative treatment options. In this blog post, I’ll discuss our work to characterize the safety and pharmacokinetic (PK) profile of avibactam.

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Topics: Drug Safety, Model-based Drug Development
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