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GLPG1972 600 mg oral solution…

Bioavailability Study With GLPG1972

Ensayo de Lakefront Biotherapeutics NV en Artrosis.

Más ensayos de: Artrosis.

Fase

Fase 1

Estado

Completado

Participantes

12

previstos

Centros

1

Fin del objetivo primario

jul 2016

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, abierto. Comenzó en jul 2016.

Qué mide

Maximum observed plasma concentration (Cmax) of GLPG1972 (From pre-dose (period 1) until 6 days after the last dose (period 3)) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis is an open-label study to determine the pharmacokinetics of a new tablet formulation of GLPG1972 and to compare it with this of the liquid solution used during the First-in-Human study (GLPG1972-CL-101). The impact of food intake on the oral bioavailability of GLPG1972 administered as tablet will also be investigated in this study. A dose of 600 mg has been selected. The study is a phase I randomized open-label cross-over study with three single dose treatments: A) 600 mg GLPG1972 oral solution after overnight fast, B) 600 mg GLPG1972 oral tablet after overnight fast, C) 600 mg GLPG1972 oral tablet 30 minutes after high-fat high-calorie breakfast. A washout of at least 6 days between subsequent dosing days is respected so that no measurable plasma levels or biologically significant effects are remaining. There will be frequent assessment of adverse experiences post-dose. Twelve healthy male subjects will be selected according to the inclusion and exclusion criteria and 2 subjects each will be randomized to one of the 6 treatment sequences (ABC, ACB, BAC, BCA, CAB, CBA)

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Ficha completa en ClinicalTrials.gov (NCT02851485), actualizada en oct 2016.