PI-076 - PATIENT-CENTRIC MICROSAMPLING VERSUS TRADITIONAL BLOOD SAMPLING: A PHARMACOKINETIC STUDY OF ZAVEGEPANT

M. Shahin¹, O. Fisniku², D. Ding³, X. Wan³, S. Dubrovin⁴, K. Matschke⁵, R. Fountaine³, J. Liu⁶; ¹Pfizer Research & Development, Groton, CT, USA, ²Pfizer Inc, Lake Forest, IL, United States, ³Pfizer, Groton, Connecticut, USA, ⁴Pfizer, Moscow, USA, ⁵Pfizer, Inc., Collegeville, PA, United States, ⁶Pfizer Inc, Groton, CT, United States.

Background: Patient-centric microsampling has the potential to transform clinical trials as it allows for remote self-collection, with minute sample volume, and a potentially less invasive collection method in comparison to conventional blood collection methods. Herein, we aimed to compare the pharmacokinetics (PK) of zavegepant (zav) 10 mg nasal spray from samples collected using Tasso capillary vs. conventional venous sampling.

Methods: In this open-label, non-randomized, single dose, crossover study, 14 healthy participants used Tasso-Plus device (n=7; produces serum samples) or Tasso-M20 (n=7; produces dried blood samples) for PK sampling after the administration of a zav 10 mg dose. Concurrent venous blood samples were collected at the same time as Tasso capillary blood samples at the following time points: 30 minutes, 1-, 2-, 4-, 8-, and 12-hours post-dose. PK parameters were calculated using noncompartmental methods. Natural log-transformed AUClast and Cmax of zav were analyzed using a mixed-effects model with blood collection as a fixed effect and participant as a random effect.

Results: Out of the two Tasso devices tested, the results of the Tasso serum device (Tasso-Plus) showed successful bridging with the venous phlebotomy sampling method. In brief, mean zav concentration-time profiles were similar between Tasso capillary serum and venous plasma. Additionally, the 90% confidence intervals for the geometric mean ratios for AUClast (91.19, 90% CI:86.43, 96.22) and Cmax (91.11, 90% CI:86.32, 96.18) of Tasso capillary serum (Test) vs. venous plasma (Reference) were wholly contained within the bioequivalence acceptance range (80 - 125%).

Conclusion: The results of this study confirm the feasibility of using the Tasso serum device as a reliable patient-centric collection method for PK analysis of zavegepant.