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GLPG3121
A Study to Evaluate How Well Single and Multiple Doses of GLPG3121-modified Release Formulation Are Tolerated in Healthy, Adult Subjects
Ensayo de Lakefront Biotherapeutics NV en Voluntarios sanos.
- Fase
- Fase 1
- Estado
- Completado
- Participantes
- 50
- Centros
- 1
- Fin del objetivo primario
- nov 2021
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en abr 2021.
Qué mide
Frequency and severity of treatment emergent adverse events (TEAEs), treatment-emergent serious adverse events, and TEAEs leading to treatment discontinuations (From screening through study completion, an average of 8 months) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroThe aim of the study is to examine the safety and tolerability of GLPG3121-modified release formulation when given to healthy male subjects once as a single dose or multiple times over a period of 14 days in fasting condition or after a standard breakfast. The study will evaluate how the body absorbs and breaks down GLPG3121, and how GLPG3121 and the major breakdown product of GLPG3121 are eliminated from the body. In addition, the study will investigate the effect of food (high-fat) after a single oral dose of GLPG3121 as modified release tablet.
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Todos los de LKFT, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT04856358), actualizada en sep 2024.