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GLPG3067 single dose
A Study to Assess Safety, Tolerability and Pharmacokinetics of GLPG3067 in Healthy Subjects.
Ensayo de Lakefront Biotherapeutics NV en Voluntarios sanos.
- Fase
- Fase 1
- Estado
- Completado
- Participantes
- 81
- Centros
- 1
- Fin del objetivo primario
- feb 2018
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en mar 2017.
Qué mide
Change versus placebo in the proportion of subjects with adverse events (Between screening and 14 days after the last dose) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroThe study is a First-in-Human, Phase I, randomized, double-blind, placebo-controlled, single center study, evaluating single and multiple ascending oral doses of GLPG3067 and the combination of GLPG3067 and GLPG2222 and the combination of GLPG3067,GLPG2222 and GLPG2737 given for 14 days in healthy women of non-childbearing potential. The purpose of the study is to evaluate the safety and tolerability of single ascending oral doses and multiple ascending oral doses of GLPG3067 given to healthy women of non-childbearing potential compared to placebo, as well as of multiple oral doses of the combination of GLPG3067/GLPG2222 compared to matching placebo for each compound and multiple oral doses of the combination of GLPG3067/GLPG2222/GLPG2737 compared to matching placebo for each compound.
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Todos los de LKFT, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT03128606), actualizada en abr 2018.