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Patient Centric Microsampling to Support Paxlovid Clinical Development: Bridging and Implementation.

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Area of Science:

  • Pharmacology
  • Clinical Trials
  • Drug Development

Background:

  • Nirmatrelvir, co-packaged with ritonavir as PAXLOVID, is an oral treatment for COVID-19.
  • The drug received FDA Emergency Use Authorization and subsequent approval for treating SARS-CoV-2 infections.

Purpose of the Study:

  • To evaluate the utility of at-home capillary blood sampling using the Tasso-M20 device for pharmacokinetic analysis of nirmatrelvir.
  • To demonstrate concordance between capillary blood samples and traditional venous plasma samples.
  • To assess the feasibility and operational challenges of implementing at-home sampling in global clinical trials.

Main Methods:

  • Pharmacokinetic (PK) capillary blood sampling at-home using the Tasso-M20 device was integrated into Phase II/III outpatient and clinical pharmacology studies.
  • Concentrations and PK parameters from Tasso dried blood samples were compared with those from venous plasma samples.
  • A two-compartment population PK model was used to bridge data from both sampling methods.

Main Results:

  • At-home Tasso sampling successfully complemented venous sampling, enriching the PK dataset and reducing patient site visits.
  • Bridging analyses demonstrated concordance/equivalence between venous plasma and Tasso dried blood results.
  • Operational challenges were managed effectively, with over 800 samples collected and less than 3% deemed unusable.

Conclusions:

  • At-home capillary blood sampling with the Tasso-M20 device is a reliable and convenient method for nirmatrelvir pharmacokinetic studies.
  • This approach enhances flexibility in clinical trial design and supports broader implementation in future research.
  • The experience gained provides valuable insights for optimizing at-home sampling strategies in global drug development programs.