A phase 1, multicenter, open-label study to evaluate the pharmacokinetics, safety, and tolerability of a single dose of rimegepant in children (aged ≥6 to <12 years) with a history of migraine
Abstract
Objective: To evaluate pharmacokinetics (PK), safety, and tolerability of a weight-adjusted dose of rimegepant orally disintegrating tablet (ODT) in children (aged ≥6 to <12 years) with a history of migraine.
Background: Rimegepant 75 mg ODT is approved for acute treatment of migraine (with or without aura) and preventive treatment of episodic migraine in adults. Studies of rimegepant in pediatric populations have not been conducted to date.
Methods: In this phase 1 open-label study, a single dose of rimegepant ODT was administered, based on body weight, to children aged ≥6 to 30 kg to ≤50 kg received 50 mg (2 × 25 mg; group 2; n = 9), and children >50 kg received 75 mg (group 3; n = 5). Blood samples were collected pre-dose and 0.5, 1.25, 3.5, and 18 h post-dose and then analyzed using a validated bioanalytical assay. Rimegepant PK parameters, including area under the plasma concentration-time curve (AUC) from time zero to infinity (AUCinf), AUC from time zero to 24 h after dosing, maximum plasma concentration (Cmax), and time to Cmax were estimated using a population PK approach in which pediatric PK data from this study were used to update a previous rimegepant population PK model developed with adult data. A safety follow-up phone call was conducted 4 days after dosing.
Results: Twenty participants with ≥1 post-dose PK sample were included in PK analyses. All 21 participants treated were analyzed for safety. A majority of the study population was White (67%) and female…
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: 21 participants or records.
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