Clinical application of volumetric absorptive microsampling to the gefapixant development program

Bioanalysis. 2020 Jul;12(13):893-904. doi: 10.4155/bio-2020-0074. Epub 2020 Jul 10.

Abstract

In this paper we show the application of the Tasso OnDemand™, a novel automated sample collection device, in conjunction with volumetric absorptive microsampling (VAMS) for the development of gefapixant, a P2X3 receptor antagonist currently under clinical development for the treatment of refractory and unexplained chronic cough and endometriosis-related pain. A LC-MS/MS bioanalytical method was developed and validated using VAMS to support this development program. This method was utilized in a drug-drug interaction study to establish a mathematical bridging relationship with data obtained from a validated plasma assay used to support the program. The VAMS bioanalytical method and the predictability of the mathematical relationship is reported and discussed here.

Keywords: Tasso OnDemand; VAMS; dried blood; gefapixant.

MeSH terms

  • Blood Specimen Collection / instrumentation*
  • Humans
  • Limit of Detection
  • Microtechnology / instrumentation*
  • Pyrimidines / blood*
  • Sulfonamides / blood*

Substances

  • Pyrimidines
  • Sulfonamides
  • Gefapixant