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GLPG1837 single ascending doses

First-in-Human Single and Multiple Dose of GLPG1837

Ensayo de Lakefront Biotherapeutics NV en Voluntarios sanos.

Fase

Fase 1

Estado

Completado

Participantes

64

previstos

Centros

1

Fin del objetivo primario

sep 2015

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en dic 2014.

Qué mide

Number of subjects with adverse events (Between screening and 7-10 days after the last dose) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe purpose of this First-in-Human study is to evaluate the safety and tolerability after single ascending oral doses of GLPG1837 given to healthy subjects, compared to placebo. Also, the safety and tolerability of multiple ascending oral doses of GLPG1837 given to healthy subjects daily for 14 days compared to placebo, will be evaluated. Furthermore, during the course of the study after single and multiple oral dose administrations, the amount of GLPG1837 and its metabolite present in the blood and urine (pharmacokinetics) will be characterized. The effect of food on the pharmacokinetics of GLPG1837 and its metabolite will also be evaluated. The potential of cytochrome P450 (CYP)3A4 induction after repeated dosing with GLPG1837 will be explored as well.

Más ensayos de LKFT

Todos los de LKFT, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT02325037), actualizada en sep 2015.