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GLPG1205 single ascending doses

First-in-Human Single and Multiple Dose of GLPG1205

Ensayo de Lakefront Biotherapeutics NV en Voluntarios sanos.

Fase

Fase 1

Estado

Completado

Participantes

40

previstos

Centros

1

Fin del objetivo primario

sep 2013

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en jun 2013.

Qué mide

Safety and tolerability after single dose (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 GLPG1205 given to healthy male subjects, compared to placebo. Also, the safety and tolerability of multiple ascending oral doses of GLPG1205 given to healthy male 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 GLPG1205 present in the blood and urine (pharmacokinetics) as well as the receptor occupancy by GLPG1205 in blood samples (pharmacodynamics) will be characterized compared to placebo. Also, the potential of cytochrome P450 (CYP)3A4 induction after repeated dosing with GLPG1205 will be explored.

Más ensayos de LKFT

Todos los de LKFT, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT01887106), actualizada en oct 2013.