Clinical application of volumetric absorptive microsampling to the gefapixant development program.

Area of Science:

• Pharmacology
• Analytical Chemistry
• Clinical Development

Background:

• Gefapixant is a P2X3 receptor antagonist for chronic cough and endometriosis pain.
• Traditional blood sampling can be invasive and burdensome for patients.
• Novel automated devices offer potential for improved sample collection.

Purpose of the Study:

• To apply Tasso OnDemand™ and volumetric absorptive microsampling (VAMS) for gefapixant analysis.
• To develop and validate a LC-MS/MS bioanalytical method using VAMS.
• To establish a mathematical bridging relationship between VAMS and plasma assays.

Main Methods:

• Utilized Tasso OnDemand™ for automated sample collection.
• Developed and validated a liquid chromatography-tandem mass spectrometry (LC-MS/MS) assay with VAMS.
• Conducted a drug-drug interaction study to bridge VAMS and plasma data.

Main Results:

• Successfully developed and validated a VAMS-based bioanalytical method for gefapixant.
• Established a predictable mathematical relationship between VAMS and plasma assay results.
• Demonstrated the utility of VAMS for supporting gefapixant clinical development.

Conclusions:

• The Tasso OnDemand™ device combined with VAMS provides a reliable method for gefapixant analysis.
• The validated VAMS method and bridging relationship support drug-drug interaction studies.
• This approach enhances the efficiency and patient-friendliness of gefapixant clinical trials.