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 (Cmax). Secondary parameters included time to Cmax (median, 0.58 h), apparent clearance (geometric mean, 186.8 L/h), apparent volume of distribution (geometric mean, 2943 L), and terminal half-life (arithmetic mean, 11.0 h). Results were comparable to exposures observed previously in non-Asian healthy participants following a single intranasal dose of zavegepant 10 mg. Zavegepant demonstrated a favorable safety profile, with no serious or severe adverse events and no clinically relevant findings regarding laboratory tests, vital signs, or electrocardiograms observed.
How strong is the evidence?
Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 12 participants or records.
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