Overview

Bioavailability Study With GLPG1972

Status:
Completed
Trial end date:
2016-08-01
Target enrollment:
Participant gender:
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)
Phase:
Phase 1
Details
Lead Sponsor:
Galapagos NV
Collaborator:
PRA Health Sciences
Treatments:
Pharmaceutical Solutions