A Pharmacokinetic Study of Zavegepant Nasal Spray in Healthy Adults Comparing Conventional Venous Blood Sampling With Patient‐Centric Microsampling
ABSTRACT This Phase 1, non‐randomized, open‐label, 2‐period study compared the pharmacokinetics (PK) of zavegepant nasal spray, using samples collected via patient‐centric microsampling (PCS) devices, with those collected through venous phlebotomy (NCT05948085). Fourteen healthy participants receive...
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| Format: | Article |
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Wiley
2025-06-01
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| Series: | Clinical and Translational Science |
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| Online Access: | https://doi.org/10.1111/cts.70199 |
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| author | Mohamed H. Shahin Ogert Fisniku Ding Ding Katty Wan Sergey Dubrovin Kyle Matschke Olga Kavetska Robert Fountaine Jing Liu |
| author_facet | Mohamed H. Shahin Ogert Fisniku Ding Ding Katty Wan Sergey Dubrovin Kyle Matschke Olga Kavetska Robert Fountaine Jing Liu |
| author_sort | Mohamed H. Shahin |
| collection | DOAJ |
| description | ABSTRACT This Phase 1, non‐randomized, open‐label, 2‐period study compared the pharmacokinetics (PK) of zavegepant nasal spray, using samples collected via patient‐centric microsampling (PCS) devices, with those collected through venous phlebotomy (NCT05948085). Fourteen healthy participants received a single intranasal dose of 10 mg zavegepant on Days 1 and 2. Blood samples for PK analysis were collected at 0.5, 1, 2, 4, 8, and 12 h post dose on Day 1 using the Tasso‐Plus device (n = 7; produces serum samples), Tasso‐M20 (n = 7; produces dried blood samples), and venous phlebotomy (n = 14). PK parameters were calculated using non‐compartmental methods. Natural log‐transformed areas under the plasma/serum concentration‐time profile from time zero to the time of the last quantifiable concentration (AUClast) and maximum serum/plasma concentration (Cmax) of zavegepant were analyzed using a mixed‐effects model, with blood collection as a fixed effect and participant as a random effect. Of the two PCS devices assessed, the results of the Tasso‐Plus device showed successful bridging with venous phlebotomy sampling. For Tasso‐Plus versus venous phlebotomy, 39 of 41 (95.1%) data pairs met concentration correlation criteria (difference within 20% of the mean), median zavegepant concentration‐time profiles were comparable, and 90% confidence intervals for geometric mean ratios for AUClast and Cmax were wholly within the range of bioequivalence acceptance (80%–125%). The results of this study confirm that it is feasible to use serum derived from Tasso‐Plus collection of whole capillary blood as a reliable PCS approach for PK analysis of zavegepant. |
| format | Article |
| id | doaj-art-23c62f67cba84f779fd4df5c12df7a40 |
| institution | Kabale University |
| issn | 1752-8054 1752-8062 |
| language | English |
| publishDate | 2025-06-01 |
| publisher | Wiley |
| record_format | Article |
| series | Clinical and Translational Science |
| spelling | doaj-art-23c62f67cba84f779fd4df5c12df7a402025-08-20T03:29:52ZengWileyClinical and Translational Science1752-80541752-80622025-06-01186n/an/a10.1111/cts.70199A Pharmacokinetic Study of Zavegepant Nasal Spray in Healthy Adults Comparing Conventional Venous Blood Sampling With Patient‐Centric MicrosamplingMohamed H. Shahin0Ogert Fisniku1Ding Ding2Katty Wan3Sergey Dubrovin4Kyle Matschke5Olga Kavetska6Robert Fountaine7Jing Liu8Pfizer Inc. Groton Connecticut USAPfizer Inc. Lake Forest Illinois USAPfizer Inc. Groton Connecticut USAPfizer Inc. La Jolla California USAPfizer Moscow RussiaPfizer Inc. Collegeville Pennsylvania USAPfizer Inc. Groton Connecticut USAPfizer Inc. Groton Connecticut USAPfizer Inc. Groton Connecticut USAABSTRACT This Phase 1, non‐randomized, open‐label, 2‐period study compared the pharmacokinetics (PK) of zavegepant nasal spray, using samples collected via patient‐centric microsampling (PCS) devices, with those collected through venous phlebotomy (NCT05948085). Fourteen healthy participants received a single intranasal dose of 10 mg zavegepant on Days 1 and 2. Blood samples for PK analysis were collected at 0.5, 1, 2, 4, 8, and 12 h post dose on Day 1 using the Tasso‐Plus device (n = 7; produces serum samples), Tasso‐M20 (n = 7; produces dried blood samples), and venous phlebotomy (n = 14). PK parameters were calculated using non‐compartmental methods. Natural log‐transformed areas under the plasma/serum concentration‐time profile from time zero to the time of the last quantifiable concentration (AUClast) and maximum serum/plasma concentration (Cmax) of zavegepant were analyzed using a mixed‐effects model, with blood collection as a fixed effect and participant as a random effect. Of the two PCS devices assessed, the results of the Tasso‐Plus device showed successful bridging with venous phlebotomy sampling. For Tasso‐Plus versus venous phlebotomy, 39 of 41 (95.1%) data pairs met concentration correlation criteria (difference within 20% of the mean), median zavegepant concentration‐time profiles were comparable, and 90% confidence intervals for geometric mean ratios for AUClast and Cmax were wholly within the range of bioequivalence acceptance (80%–125%). The results of this study confirm that it is feasible to use serum derived from Tasso‐Plus collection of whole capillary blood as a reliable PCS approach for PK analysis of zavegepant.https://doi.org/10.1111/cts.70199bioequivalencepatient centered microsamplingpharmacokineticssafetyzavegepant |
| spellingShingle | Mohamed H. Shahin Ogert Fisniku Ding Ding Katty Wan Sergey Dubrovin Kyle Matschke Olga Kavetska Robert Fountaine Jing Liu A Pharmacokinetic Study of Zavegepant Nasal Spray in Healthy Adults Comparing Conventional Venous Blood Sampling With Patient‐Centric Microsampling Clinical and Translational Science bioequivalence patient centered microsampling pharmacokinetics safety zavegepant |
| title | A Pharmacokinetic Study of Zavegepant Nasal Spray in Healthy Adults Comparing Conventional Venous Blood Sampling With Patient‐Centric Microsampling |
| title_full | A Pharmacokinetic Study of Zavegepant Nasal Spray in Healthy Adults Comparing Conventional Venous Blood Sampling With Patient‐Centric Microsampling |
| title_fullStr | A Pharmacokinetic Study of Zavegepant Nasal Spray in Healthy Adults Comparing Conventional Venous Blood Sampling With Patient‐Centric Microsampling |
| title_full_unstemmed | A Pharmacokinetic Study of Zavegepant Nasal Spray in Healthy Adults Comparing Conventional Venous Blood Sampling With Patient‐Centric Microsampling |
| title_short | A Pharmacokinetic Study of Zavegepant Nasal Spray in Healthy Adults Comparing Conventional Venous Blood Sampling With Patient‐Centric Microsampling |
| title_sort | pharmacokinetic study of zavegepant nasal spray in healthy adults comparing conventional venous blood sampling with patient centric microsampling |
| topic | bioequivalence patient centered microsampling pharmacokinetics safety zavegepant |
| url | https://doi.org/10.1111/cts.70199 |
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