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GLPG0974
Multiple Ascending Dose Study of GLPG0974 in Healthy Subjects
Ensayo de Lakefront Biotherapeutics NV en Voluntarios sanos.
- Fase
- Fase 1
- Estado
- Completado
- Participantes
- 32
- Centros
- 1
- Fin del objetivo primario
- feb 2013
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en oct 2012.
Qué mide
Safety and tolerability (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 study is to evaluate the safety and tolerability after multiple ascending oral doses of GLPG0974 given to healthy male subjects for 14 days, compared to placebo. Furthermore, during the course of the study, the amount of GLPG0974 present in the blood and urine (pharmacokinetics) as well as the effects of GLPG0974 on mechanism of action-related parameters in the blood and stool samples (pharmacodynamics) will be characterized compared to placebo. Also, the effect of the compound on glucose tolerance will be explored as well as the potential of cytochrome P450 (CYP)3A4 induction by repeated dosing with GLPG0974.
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Todos los de LKFT, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT01721980), actualizada en feb 2013.