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GLPG1837 500 mg

A Phase I, Open Interaction Study Between GLPG1837 and Midazolam in Healthy Male Subjects

Ensayo de Lakefront Biotherapeutics NV en Voluntarios sanos.

Fase

Fase 1

Estado

Completado

Participantes

24

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 (1'-OH) Midazolam in plasma before and after multiple oral doses of GLPG1837 (Between Day 1 (predose) and Day 13 (24h post last dose on Day 12)) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis will be a drug-drug interaction study to evaluate the effect of multiple oral doses of GLPG1837 on the single dose pharmacokinetic profile of midazolam administered in fed healthy male subjects. Each subject will receive a single oral dose of midazolam (2 mg) on 2 occasions: on Day 1, before dosing with GLPG1837 and on Day 12 co-administered with GLPG1837, after multiple oral doses of GLPG1837 (daily for 10 days, from Day 2 until Day 11). Also, the safety and tolerability of multiple oral doses of GLPG1837 co-administered with midazolam in healthy male subjects will be evaluated. A first dose group of 12 subjects will receive a total daily dose of 500 mg (250 mg b.i.d.) GLPG1837 and a second dose group of 12 subjects will receive a total daily dose of 1000 mg (500 mg b.i.d.) GLPG1837.

Más ensayos de LKFT

Todos los de LKFT, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT02562950), actualizada en oct 2015.