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Eplivanserin · PKiDs

Single Dose Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Evaluation of Eplivanserin in Children With Insomnia

Ensayo de Sanofi en Sleep Initiation and Maintenance Disorders (del registro, en inglés).

Fase

Fase 1

Estado

Completado

Participantes

41

previstos

Centros

1

Fin del objetivo primario

dic 2009

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, no aleatorizado, abierto. Comenzó en jun 2009.

Qué mide

Safety in terms of adverse events, laboratory tests, vital signs, ECGs (Up to 12 days following single dose administration) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroGiven the potential age-related differences in safety, tolerability, pharmacokinetics, and differences in sleep architecture in young children versus adolescent versus adult, studies to identify the appropriate drug and dosage for children of all ages are essential in addressing this health problem that impacts the child and their family. The objective of this study is to evaluate the safety, pharmacokinetics and preliminary efficacy of eplivanserin. Primary objective: to assess the safety and tolerability after administration of single ascending oral doses of eplivanserin to children aged 6-17 years with insomnia of various origins. To assess the pharmacokinetics of eplivanserin (and active metabolite: SR141342) after administration of single ascending oral doses of eplivanserin to children aged 6-17 years with insomnia of various origins. Secondary objective: to assess the effect of single ascending oral doses of eplivanserin on global sleep parameters and sleep architecture measured via polysomnography recordings in children aged 6-17 years old with insomnia of various origins.

Más ensayos de SNY

Todos los de SNY, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT00913614), actualizada en nov 2010.