Bioavailability Study With GLPG1972

Osteoarthritis Clinical Trial

Official title: 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

Clinical Trial 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)

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis

• NCT number: NCT02851485
• Study type: Interventional
• Source: Galapagos NV
• Status: Completed
• Phase: Phase 1
• Start date: July 2016
• Completion date: August 2016