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

A Randomized, Open-label, Four-period, Single-dose Cross-over Study in Healthy Male Subjects to Assess the Relative Bioavailability of Two Candidate Tablet Formulations Versus the Current Tablet Formulation of GLPG1972 and to Assess the Food Effect of the Tablet Formulation Selected for Phase 3 in Period 4

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Galapagos NV · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	GLPG1972 - A	Film-coated tablet, formulation A
DRUG	GLPG1972 - B	Film-coated tablet, formulation B
DRUG	GLPG1972 - C	Film-coated tablet, formulation C

Timeline

• Start date: 2019-10-09
• Primary completion: 2019-12-13
• Completion: 2019-12-13
• First posted: 2019-10-24
• Last updated: 2020-01-13

Locations

1 site across 1 country: United Kingdom