NCT03800472

A Study Investigating the Safety, Absorption and Elimination of GLPG3312, a New Drug in the Treatment of Inflammatory Diseases

A Phase I, Randomized, Double-blind, Placebo-controlled, Single-center Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Including the Effect of Food, and Pharmacodynamics of Single and Multiple Ascending Oral Doses of GLPG3312, in Adult, Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 95 (actual)
• Sponsor: Galapagos NV · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to investigate how safe 2 different formulations (immediate-release (IR) and modified-release (MR) tablets) of the new compound GLPG3312 are and how well they are tolerated when they are administered to healthy volunteers. Immediate-release and modified-release tablets contain the same active ingredient, but the modified-release tablet is covered with a protective layer, so it will dissolve in the intestines and not in the stomach. GLPG3312 has not been administered to humans before. Next to assessing the safety and tolerability, the purpose of this study is to investigate how food affects how quickly and to what extent GLPG3312 in a modified release formulation is absorbed and eliminated from the body. In addition, the effect of GLPG3312 on the body will be investigated by evaluating the effect of GLPG3312 on markers of the immune response.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	GLPG3312 IR	GLPG3312 IR tablets, up to 4 single ascending oral doses (A, B, C, D).
DRUG	Placebo	Placebo tablets
DRUG	GLPG3312 MR	GLPG3312 MR film-coated tablets, up to 4 single ascending oral doses (H, I, J, K).
DRUG	GLPG3312 FE MR	GLPG3312 MR film-coated tablets, single oral dose (N) on 2 occasions, i.e. in fed state after a high-fat high-calorie breakfast, and in fasted state.
DRUG	GLPG3312 MR	GLPG3312 MR film-coated tablets, up to 2 multiple ascending oral doses (O, P).
DRUG	GLPG3312 MR	GLPG3312 MR optimized film-coated tablets, up to 3 multiple ascending oral doses (Q, R, S).
DRUG	Placebo	Placebo optimized tablets

Timeline

• Start date: 2019-01-15
• Primary completion: 2020-03-10
• Completion: 2020-03-10
• First posted: 2019-01-11
• Last updated: 2020-03-19

Locations

1 site across 1 country: Netherlands