Pharmacokinetics of naratriptan in adolescent subjects with a history of migraine

Narahiptan is a novel 5-HT1 agonist developed to treat acute migraine. The study objective was to characterize the pharmacokinetics of oral naratripta n in adolescent migraine patients outside a migraine attack. Subjects recei ved a single 2.5 mg naratriptan tablet. Serial serum samples for naratripta n concentrations were collected over 24 hours. Blood pressure, pulse rate, and 12-lead ECG were recorded at baseline and at regular intervals after do sing. Seven patients-3 males and 4 females, 12 to 16 years of age-received drug and completed the study. The geometric mean and 95% confidence interva l maximum concentration (C-max) was 8.0 ng/mL (5.9-10.7), elimination half- life (t(1/2) was 4.9 hours (4.5-5.4), area under the concentration-time cur ve (AUC) was 74.6 ng(.)h/ml (56.6-98.2), and apparent total clearance (Cl/F ) was 558.8 ml/min (424.3-735.9). The median time to maximal concentration (t(max)) was 4 hours, with a range of 1.5 to 4. Blood pressure, pulse rate, and ECG parameters did not change significantly from baseline. No serious adverse events or subject withdrawal after drug administration occurred. Or al naratriptan pharmacokinetic parameters in adolescents were similar to va lues reported in adults. Naratriptan doses for adolescents older than 12 ye ars of age would be expected to be similar to adult doses. (C) 2001 the Ame rican College of Clinical Pharmacology.