drugset / Trial / NCT04137341

A Study in Healthy Volunteers to Compare Different Tablet Formulations of the Test Medicine, GLPG1972, Against the Current Tablet Formulation, and to Assess the Effect Food Has on One of the Test Medicines

NCT04137341 ↗

Phase 1 Completed 18 enrolled Lakefront Biotherapeutics NV
RandomizedCrossoverOpen-labelBasic science

Summary

The sponsor wants to investigate two new tablet formulations (recipes) of the test medicine, and how they are taken up by the body in comparison to the current tablet formulation (study periods 1 to 3). If one of the 2 new tablets has a more favourable profile than the current tablet in periods 1 to 3, the sponsor will then investigate the effect that food has on this new tablet in study period 4. However, if the new tablets do not have a more favourable profile than the current tablet, the food effect does not need to be investigated and study period 4 will not be needed.

Timeline

Start
2019-10-09
Primary completion
2019-12-13
Completion
2019-12-13

Drugs

EvaluationDrugModalityDoseRoute
Subject ALDUMASTAT Small molecule 300 mg Oral

Indications

No indication recorded.