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drugset / Trial / NCT04856358

A Study to Evaluate How Well Single and Multiple Doses of GLPG3121-modified Release Formulation Are Tolerated in Healthy, Adult Subjects

NCT04856358 ↗

Phase 1 Completed 50 enrolled Lakefront Biotherapeutics NV
RandomizedParallel-groupQuadruple-blindBasic science

Summary

The 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.

Timeline

Start
2021-04-27
Primary completion
2021-11-08
Completion
2021-11-08

Drugs

EvaluationDrugModalityDoseRoute
Subject GLPG3121 Unknown — Oral

Indications

No indication recorded.