This study is a Phase I, randomized, open-label, cross-over study with 4 single-dose treatments of GLPG1972 to compare the bioavailability of the oral wet granulation (WG) tablet relative to an oral solution and to the oral direct compression (DC) tablet after single dose intake in healthy male subjects and to evaluate the effect of food on the bioavailability of the WG oral tablet.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Oral administration of GLPG1972 in four different treatment conditions (Treatments A throug D)
SGS Belgium Life Sciences
Antwerp, Belgium
Assessment of the maximum observed plasma concentration of GLPG1972 after single oral doses
Determine bioavailability of GLPG1972 by assessing PK parameters
Time frame: on day 1 pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24 and 48 hours post doses
Assessment of plasma concentration of GLPG1972 24hrs post-dose after single oral doses
Determine bioavailability of GLPG1972 by assessing PK parameters
Time frame: At 24 hours post dose
Assessment of time to achieve the maximal plasma concentration of GLPG1972 after single oral doses
Determine bioavailability of GLPG1972 by assessing PK parameters
Time frame: on day 1 pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24 and 48 hours post doses
Assessment of the last quantifiable plasma concentration of GLPG1972 after single oral doses
Determine bioavailability of GLPG1972 by assessing PK parameters
Time frame: on day 1 pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24 and 48 hours post doses
the number of subjects with adverse events
To assess safety and tolerability of GLPG1972 given orally
Time frame: at screening, pre-dose at date 1 and post-dose at 24 and 48 hours
the number of subjects with abnormal vital signs
To assess safety and tolerability of GLPG1972 given orally
Time frame: at screening, pre-dose at date 1 and post-dose at 24 and 48 hours
the number of subjects with abnormal ECG
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To assess safety and tolerability of GLPG1972 given orally
Time frame: at screening, pre-dose at date 1 and post-dose at 24 and 48 hours
the number of subjects with abnormal laboratory assessments
To assess safety and tolerability of GLPG1972 given orally
Time frame: at screening, pre-dose at date 1 and post-dose at 24 and 48 hours