TABLE 2.

Predicted ΔΔQTcF interval at geometric mean peak zavegepant concentration (SAD and MAD studies pooled) (PK/QTc analysis population).

Zavegepant treatment	Zavegepant geometric mean C max (ng/mL)	ΔΔQTcF estimates (90% CI)
SAD study
0.1 mg	1.2	0.93 (−1.02, 2.87)
0.3 mg	1.1	0.94 (−1.01, 2.88)
1 mg	1.3	0.92 (−1.02, 2.86)
3 mg	3.7	0.80 (−1.13, 2.72)
5 mg	7.8	0.58 (−1.33, 2.48)
10 mg	13.4	0.28 (−1.62, 2.18)
20 mg	22.6	−0.21 (−2.17, 1.75)
20 mg, 2 × 10 mg sprays	33.9	−0.81 (−2.94, 1.31)
40 mg, 2 × 20 mg sprays	26.7	−0.43 (−2.43, 1.58)
MAD study
5 mg Day 1	11.4	0.39 (−1.51, 2.29)
5 mg Day 14	7.6	0.59 (−1.32, 2.50)
10 mg Day 1	16.3	0.12 (−1.79, 2.04)
10 mg Day 14	13.0	0.30 (−1.60, 2.20)
20 mg Day 1	34.7	−0.85 (−2.99, 1.28)
20 mg Day 14	40.9	−1.19 (−3.45, 1.08)
40 mg, 2 × 20 mg sprays Day 1	47.7	−1.55 (−3.98, 0.89)
40 mg, 2 × 20 mg sprays Day 8	23.0	−0.23 (−2.19, 1.73)

Note: Based on a linear mixed‐effects model with ΔQTcF as the dependent variable, time‐matched zavegepant plasma concentration as an explanatory variate, centered baseline QTcF as an additional covariate, treatment (active = 1 or placebo = 0) and time as fixed effects, and a random intercept and slope per subject. Participants who had only BLQ values for the calculation of log C _max are replaced with ½ lower limit of quantitation.

Abbreviations: BLQ, below limit of quantitation; CI, confidence interval; MAD, multiple‐ascending dose; PK, pharmacokinetics; SAD, single‐ascending dose; ΔQTcF, change from baseline in QTcF; ΔΔQTcF, placebo‐corrected change from baseline QT interval corrected using Fridericia's formula.