Pharmacokinetics of pitolisant in children and adolescents with narcolepsy

To evaluate the pharmacokinetic profile and tolerability of pitolisant, a selective histamine 3 (H3)−receptor antagonist/inverse agonist, in children and adolescents with narcolepsy. This multicenter, open-label, single-dose study of pitolisant 17.8 mg enrolled patients aged 6 through 17 years with...

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Bibliographic Details
Published in:Sleep medicine 2020-02, Vol.66, p.220-226
Main Authors: Lecendreux, Michel, Plazzi, Giuseppe, Franco, Patricia, Jacqz-Aigrain, Evelyne, Robert, Philippe, Duvauchelle, Thierry, Schwartz, Jean-Charles
Format: Article
Language:English
Subjects:
Adolescent
Adult
Age Factors
Child
Female
Human health and pathology
Humans
Life Sciences
Male
Narcolepsy
Narcolepsy - drug therapy
Pediatric
Pharmacokinetics
Piperidines - adverse effects
Piperidines - blood
Piperidines - pharmacokinetics
Pitolisant
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Summary:To evaluate the pharmacokinetic profile and tolerability of pitolisant, a selective histamine 3 (H3)−receptor antagonist/inverse agonist, in children and adolescents with narcolepsy. This multicenter, open-label, single-dose study of pitolisant 17.8 mg enrolled patients aged 6 through 17 years with a diagnosis of narcolepsy. Blood samples were collected at prespecified time points for analysis of pharmacokinetic parameters, including maximum serum concentration (Cmax) and area under the serum concentration–time curve from time 0–10 h (AUC0–10h). Pharmacokinetic parameters were compared across three prespecified age groups: younger pediatric patients (aged 6 to
ISSN:1389-9457
1878-5506
DOI:10.1016/j.sleep.2019.10.024