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GLPG3667 oral suspension

A Study to Evaluate the Effects of Single and Multiple Oral Doses of GLPG3667

Ensayo de Lakefront Biotherapeutics NV en Voluntarios sanos.

Fase

Fase 1

Estado

Completado

Participantes

52

previstos

Centros

1

Fin del objetivo primario

mar 2020

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en sep 2019.

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 5 months) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis study is a first-in-human, Phase I, randomized, double-blind, placebo-controlled, single-center, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics of GLPG3667 after oral single ascending doses (SAD) of GLPG3667 (part 1) and after oral multiple ascending doses (MAD) for 13 days of GLPG3667 (part 2) in healthy male subjects. In addition, the effect of food (FE) on safety, tolerability, and PK of GLPG3667 oral suspension will be evaluated (part 3 - will not be completed), and the relative bioavailability (rBA) of the capsule versus the oral suspension with the effect of food on the bioavailability of the capsule (part 4), both part 3 and 4 using an open-label, randomized, crossover design.

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Todos los de LKFT, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT04097938), actualizada en sep 2024.