A Phase 1 Open-Label Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of a Single Intranasal Dose of Zavegepant in Healthy Chinese Adults.

ABSTRACT: Zavegepant is the only calcitonin gene-related peptide antagonist approved as a nasal spray in the United States for acute treatment of migraine in adults with or without aura. This Phase 1, open-label study evaluated the pharmacokinetics, safety, and tolerability of a single intranasal dose of zavegepant 10 mg in 12 healthy Chinese adults. Blood samples were collected for pharmacokinetic assessment prior to dosing and from 5 min to 24 h post dose. Geometric mean values for the primary pharmacokinetic parameters were 53.53 ng h/mL for area under the plasma concentration-time curve (AUC) from time zero to infinity, 44.25 ng h/mL for AUC from time zero to time of last quantifiable concentration, and 20.32 ng/mL for maximum plasma concentration (C_max). Secondary parameters included

SUBMITTER: Wei Q 

PROVIDER: S-EPMC12811193 | biostudies-literature | 2026 Jan

REPOSITORIES: biostudies-literature