Assessing the safety, tolerability, pharmacokinetics and biodistribution of novel oral formulations of amphotericin B following single and multiple dose administration to Beagle dogs.

Assessing the safety, tolerability, pharmacokinetics and biodistribution of novel oral formulations of amphotericin B following single and multiple dose administration to Beagle dogs. Antimicrob Agents Chemother. 2020 Aug 17;: Authors: Wasan KM, Wasan EK, Hnik P Abstract The purpose of this study was to assess the safety, tolerability, pharmacokinetics and biodistribution of novel oral amphotericin B (AmpB) formulations following single and multiple oral dose administration to healthy beagle dogs. The liquid formulation of AmpB was administered to three male dogs and the capsule formulations of AmpB were administered to each of two groups of six male dogs. Blood was collected for pharmacokinetic evaluation on Day 1, 2 and 3 (up to 72 hours post-dosing). Dogs receiving the capsule formulations further received a single oral dose of 100 mg once daily for three more days and on the fourth day blood samples were taken 24 hours post-dosing and the dogs were humanely sacrificed with the removal of organs from which tissue samples were taken for analysis of AmpB content. Multiple dose studies with daily doses for 7 or 14 days were completed up to 1000 mg/day dose with the capsule formulations. All oral formulations of AmpB following both single and multiple dose administration were well tolerated in dogs and there were no relevant adverse signs observed such as changes in hematologic, coagulation or biochemistry parameters, loss of weight, ...
Source: Antimicrobial Agents and Chemotherapy - Category: Microbiology Authors: Tags: Antimicrob Agents Chemother Source Type: research