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sapropterin dihydrochloride

A Phase 1 Study to Evaluate Effects of Sapropterin Dihydrochloride on QTc Intervals in Healthy Adult Subjects

Ensayo de BIOMARIN PHARMACEUTICAL INC en Fenilcetonuria.

Más ensayos de: Fenilcetonuria.

Fase

Fase 1

Estado

Completado

Participantes

56

previstos

Centros

1

Fin del objetivo primario

ene 2009

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, triple ciego. Comenzó en oct 2008.

Qué mide

To determine if a single supratherapeutic dose of sapropterin or a single therapeutic dose of sapropterin has an effect on cardiac repolarization compared with placebo as a change from baseline measured by the subject specific QT correction formula(QTci) (Complete study) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroSapropterin dihydrochloride (subsequently referred to as sapropterin) (Kuvan®) was approved by the FDA for the treatment of hyperphenylalaninemia in 2007. Preclinical and clinical studies and post-marketing surveillance have not demonstrated any specific cardiovascular concerns with sapropterin (Kuvan®). Nonetheless, nonantiarrhythmic drugs may have the potential to prolong QT interval, leading to potentially fatal ventricular tachycardias, including torsades de pointes. As part of the post-marketing commitment, a thorough QT/QTc study will be conducted according to ICH guidelines.

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Todos los de BMRN, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT00789568), actualizada en jul 2021.