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Last Updated: January 24, 2021

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CLINICAL TRIALS PROFILE FOR GLPG1205

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Clinical Trials for GLPG1205

Trial ID Title Status Sponsor Phase Summary
NCT01887106 First-in-Human Single and Multiple Dose of GLPG1205 Completed Galapagos NV Phase 1 The purpose of this First-in-Human study is to evaluate the safety and tolerability after single ascending oral doses of GLPG1205 given to healthy male subjects, compared to placebo. Also, the safety and tolerability of multiple ascending oral doses of GLPG1205 given to healthy male subjects daily for 14 days compared to placebo, will be evaluated. Furthermore, during the course of the study after single and multiple oral dose administrations, the amount of GLPG1205 present in the blood and urine (pharmacokinetics) as well as the receptor occupancy by GLPG1205 in blood samples (pharmacodynamics) will be characterized compared to placebo. Also, the potential of cytochrome P450 (CYP)3A4 induction after repeated dosing with GLPG1205 will be explored.
NCT02143856 Oral Bioavailability of Solid Formulation of GLPG1205 With and Without Food Completed Galapagos NV Phase 1 The purpose of the study is to evaluate the amount of compound present in the blood (relative bioavailability) after a single oral administration of GLPG1205 given as a capsule formulation in fasted versus fed conditions in male healthy subjects. Also, the safety and tolerability of a single oral dose of GLPG1205 given as a capsule formulation under fasted and fed conditions will be assessed.
NCT02337608 Efficacy and Safety of GLPG1205 in Subjects With Active Ulcerative Colitis Completed Galapagos NV Phase 2 - Approximately 60 patients suffering from moderate to severe ulcerative colitis will be evaluated for improvement of disease activity (efficacy) when taking GLPG1205 or matching placebo once daily for 12 weeks in addition to their stable background treatment. - During the course of the study, patients will also be examined for any side effects that may occur (safety and tolerability), and the amount of GLPG1205 present in the blood (Pharmacokinetics) as well as the effects of GLPG1205 on disease- and mechanism of action-related parameters (Pharmacodynamics) in blood, stool and colonic biopsies will be determined.
NCT02623296 A Drug-drug Interaction Study Between GLPG1205 and a Cocktail of CYP450 Substrates in Healthy Male Subjects Completed Galapagos NV Phase 1 This will be a Phase I, randomized, double-blind, placebo-controlled, 2 period cross-over, drug-drug interaction study to evaluate the effect of multiple oral doses of GLPG1205 or placebo (daily from Day 1 to Day 12) on a single dose pharmacokinetic profile of a cocktail of CYP450 substrates administered to healthy male subjects. The cocktail of CYP450 substrates will consist of 10 mg warfarin (CYP2C9 substrate), 20 mg omeprazole (CYP2C19 substrate) and 100 mg caffeine (CYP1A2 substrate). Fourteen healthy male subjects will receive during two treatment periods from Day 1 to Day 12 a daily dose of GLPG1205 or placebo. On Day 13, a single dose of the cocktail of CYP450 substrates will be co-administered either with GLPG1205 or with placebo. The two treatment periods will be separated by a wash-out period of at least 28 days. Also, the safety and tolerability of multiple oral doses of GLPG1205 administered with or without a cocktail of CYP450 substrates in healthy male subjects will be evaluated.
NCT03725852 A Clinical Study to Test How Effective and Safe GLPG1205 is for Patients With Idiopathic Pulmonary Fibrosis (IPF) Recruiting Galapagos NV Phase 2 This is a randomized, double-blind, parallel group, placebo-controlled, multicenter, exploratory Phase II study including subjects with Idiopathic Pulmonary Fibrosis (IPF), investigating GLPG1205 of top of local standard of care (defined as receiving nintedanib, pirfenidone, or neither nintedanib or pirfenidone).
>Trial ID >Title >Status >Phase >Summary

Clinical Trial Conditions for GLPG1205

Condition Name

Condition Name for
Intervention Trials
Healthy 5
Ulcerative Colitis 1
Idiopathic Pulmonary Fibrosis 1
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Condition MeSH

Condition MeSH for
Intervention Trials
Idiopathic Pulmonary Fibrosis 1
Idiopathic Interstitial Pneumonias 1
Fibrosis 1
Ulcer 1
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Clinical Trial Locations for GLPG1205

Trials by Country

Trials by Country for
Location Trials
Belgium 4
Germany 1
Russian Federation 1
Czech Republic 1
Poland 1
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Trials by US State

Trials by US State for
Location Trials
California 1
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Clinical Trial Progress for GLPG1205

Clinical Trial Phase

Clinical Trial Phase for
Clinical Trial Phase Trials
Phase 2 2
Phase 1 5
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Clinical Trial Status

Clinical Trial Status for
Clinical Trial Phase Trials
Completed 4
Recruiting 2
Not yet recruiting 1
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Clinical Trial Sponsors for GLPG1205

Sponsor Name

Sponsor Name for
Sponsor Trials
Galapagos NV 7
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Sponsor Type

Sponsor Type for
Sponsor Trials
Industry 7
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