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Bioavailability Study With GLPG1972

Lakefront Biotherapeutics NV · 2016
ClinicalTrials.gov · Datasets · License: Public Domain · 2016
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osteoarthritis
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)
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