This study is a Phase I, randomized, open-label, cross-over study with three single-dose treatments to compare the bioavailability of an oral tablet relative to an oral capsule of GLPG1690 after single dose intake in healthy male subjects and to evaluate the effect of food on the bioavailability of the oral tablet.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Oral administration of GLPG1690 in three different treatment conditions (treatment A through C)
SGS CPU
Antwerp, Belgium
Assessment of the maximum observed plasma concentration of GLPG1690 after single oral doses
Determine the bioavailability of GLPG1690 by assessing PK parameters
Time frame: predose at day 1 and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 and 48 hours post dosing
Assessment of the time to reach the maximum observed plasma concentration of GLPG1690 after single oral doses
Determine the bioavialability of GLPG1690 by assessing PK parameters
Time frame: predose at day 1 and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 and 48 hours post dosing
Assessment of the time of the last quantifiable plasma concentration of GLPG1690 after single oral doses
Determine the bioavialability of GLPG1690 by assessing PK parameters
Time frame: predose at day 1 and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 and 48 hours post dosing
The number of subjects with adverse events
To assess safety and tolerability of GLPG1690
Time frame: Throughout the study from screening until the follow up visit (day 7 of dosing period 3)
The number of subjects with abnormal vital signs
To assess safety and tolerability of GLPG1690
Time frame: Throughout the study from screening until the follow up visit (day 7 of dosing period 3)
The number of subjects with abnormal ECG
To assess safety and tolerability of GLPG1690
Time frame: Throughout the study from screening until the follow up visit (day 7 of dosing period 3)
The number of subjects with abnormal physical examination
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To assess safety and tolerability of GLPG1690
Time frame: Throughout the study from screening until the follow up visit (day 7 of dosing period 3)
The number of subjects with abnormal laboratory analysis
To assess safety and tolerability of GLPG1690
Time frame: Throughout the study from screening until the follow up visit (day 7 of dosing period 3)