NCT02851485

Bioavailability Study With GLPG1972

Open-label Study to Compare the Bioavailability of an Oral Tablet of GLPG1972 Relative to an Oral Solution 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

This is an open-label study to determine the pharmacokinetics of a new tablet formulation of GLPG1972 and to compare it with this of the liquid solution used during the First-in-Human study (GLPG1972-CL-101). The impact of food intake on the oral bioavailability of GLPG1972 administered as tablet will also be investigated in this study. A dose of 600 mg has been selected. The study is a phase I randomized open-label cross-over study with three single dose treatments: A) 600 mg GLPG1972 oral solution after overnight fast, B) 600 mg GLPG1972 oral tablet after overnight fast, C) 600 mg GLPG1972 oral tablet 30 minutes after high-fat high-calorie breakfast. A washout of at least 6 days between subsequent dosing days is respected so that no measurable plasma levels or biologically significant effects are remaining. There will be frequent assessment of adverse experiences post-dose. Twelve healthy male subjects will be selected according to the inclusion and exclusion criteria and 2 subjects each will be randomized to one of the 6 treatment sequences (ABC, ACB, BAC, BCA, CAB, CBA)

Conditions

• Osteoarthritis

Interventions

Type	Name	Description
DRUG	GLPG1972 600 mg oral solution fasted	dosing after overnight fasting
DRUG	GLPG1972 600 mg oral tablet fasted	dosing after overnight fasting
DRUG	GLPG1972 600 mg oral tablet fed	dosing after high-fat high-calorie breakfast

Timeline

• Start date: 2016-07-01
• Primary completion: 2016-07-01
• Completion: 2016-08-01
• First posted: 2016-08-01
• Last updated: 2016-10-04

Locations

1 site across 1 country: Netherlands