NCT02562859

Oral Bioavailability of Solid Formulation of GLPG1837 With and Without Food

An Open-label Study to Compare the Oral Bioavailability of an Oral Tablet of GLPG1837 Relative to an Oral Suspension After Single-dose Intake in Healthy Subjects and to Evaluate the Effect of Food on the Oral Tablet

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Galapagos NV · Industry
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to evaluate the amount of GLPG1837 and metabolite present in the blood (relative bioavailability) after a single oral administration of 500 mg GLPG1837 given as an oral suspension under fasted conditions as well as a tablet formulation under fasted and fed conditions, in male healthy subjects. Also, the safety and tolerability of a single oral dose of 500 mg GLPG1837 given as an oral suspension under fasted conditions as well as a tablet formulation under fasted and fed conditions, will be assessed. Twelve subjects will receive GLPG1837 on 3 occasions as single dose administrations: as an oral suspension fasted, as an oral tablet, fed and fasted. Treatment administrations will be separated by a wash-out period of at least 6 days.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	500 mg GLPG1837 as oral suspension	A single dose of 500 mg GLPG1837 administered as oral suspension
DRUG	500 mg GLPG1837 as oral tablet	A single dose of 500 mg GLPG1837 administered as oral tablet

Timeline

• Start date: 2015-09-01
• Primary completion: 2015-10-01
• Completion: 2015-10-01
• First posted: 2015-09-29
• Last updated: 2015-10-23

Locations

1 site across 1 country: Belgium