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tasimelteon 20 mg capsule

Open Label Study to Assess the Absolute Bioavailability of Tasimelteon (HETLIOZ™)

Ensayo de Vanda Pharmaceuticals Inc. en Trastorno de sueno-vigilia no ajustado a 24 horas.

Fase

Fase 4

Estado

Completado

Participantes

14

previstos

Fin del objetivo primario

may 2014

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, abierto. Comenzó en may 2014.

Qué mide

Biodisponibilidad absoluta tras una dosis oral unica de Hetlioz™ (Tasimelteon) 20mg (pre-dose, -0.125, 0, 0.083, 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroHetlioz™ (tasimelteon) is used in the treatment of Non-24-Hour-Sleep-Wake Disorder (Non-24). Non-24 is very common in people who are totally blind because light can not reset their body clock. This causes the internal sleep-wake cycle to be out of sync with the 24-hour day-night. Non-24 is a serious, chronic circadian rhythm disorder in the blind that causes nighttime sleep problems and a wide range of daytime difficulties, including an overwhelming urge to nap. Tasimelteon will be given in two ways; orally (by mouth) as a 20 mg capsule and intravenously (I.V.) by infusion through a catheter (not an injection) into a vein. The oral administration is approved by the FDA. The I.V. administration is considered investigational as it has not been approved by the FDA. This will be the first time tasimelteon will be given to humans by intravenous (I.V.) injection. The purposes of this research study are to: * assess how quickly a single 20 mg oral dose of tasimelteon is absorbed into the body; * evaluate the single-dose pharmacokinetics of tasimelteon after a single 20 mg oral dose and after a single 2 mg I.V. dose; * evaluate the single-dose pharmacokinetics of tasimelteon metabolites after a single 20 mg oral dose and after a single 2 mg I.V. dose; * evaluate the safety and tolerability of a single 20 mg oral dose of tasimelteon; and * evaluate the safety and tolerability of a single 2 mg I.V. dose of tasimelteon. Pharmacokinetics (PK) is the study of how a drug is absorbed, distributed, metabolized, and eventually eliminated by the body. Pharmacokinetics is what the body does to the drug. Blood samples will be taken throughout the study for PK analysis.

Más ensayos de VNDA

Todos los de VNDA, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT02130999), actualizada en jul 2016.