Calendario›LKFT›500 mg GLPG1837 as oral…

500 mg GLPG1837 as oral…

Oral Bioavailability of Solid Formulation of GLPG1837 With and Without Food

Ensayo de Lakefront Biotherapeutics NV en Voluntarios sanos.

Fase

Fase 1

Estado

Completado

Participantes

12

previstos

Centros

1

Fin del objetivo primario

oct 2015

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, abierto. Comenzó en sep 2015.

Qué mide

The maximum observed concentration (Cmax) of GLPG1837 (metabolite) in plasma (Between Day 1 (predose) in period 1 (first dose of GLPG1837) and Day 4 (72h post dose) in period 3 (last dose of GLPG1837)) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe purpose of the study is to evaluate the amount of GLPG1837 and metabolite present in the blood (relative bioavailability) after a single oral administration of 500 mg GLPG1837 given as an oral suspension under fasted conditions as well as a tablet formulation under fasted and fed conditions, in male healthy subjects. Also, the safety and tolerability of a single oral dose of 500 mg GLPG1837 given as an oral suspension under fasted conditions as well as a tablet formulation under fasted and fed conditions, will be assessed. Twelve subjects will receive GLPG1837 on 3 occasions as single dose administrations: as an oral suspension fasted, as an oral tablet, fed and fasted. Treatment administrations will be separated by a wash-out period of at least 6 days.

Más ensayos de LKFT

Todos los de LKFT, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT02562859), actualizada en oct 2015.