The purpose of the study is to evaluate the amount of compound present in the blood (relative bioavailability) after a single oral administration of GLPG1205 given as a capsule formulation in fasted versus fed conditions in male healthy subjects. Also, the safety and tolerability of a single oral dose of GLPG1205 given as a capsule formulation under fasted and fed conditions will be assessed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
A single dose of 100 mg GLPG1205 administered as two capsules of 50 mg
SGS LSS Clinical Pharmacology Unit Antwerp
Antwerp, Antwerp, Belgium
The amount of GLPG1205 in plasma
To characterize and compare the amount of GLPG1205 in plasma ( relative bioavailability) in male healthy subjects after a single administration of a capsule formulation in a fasted versus fed condition.
Time frame: From predose up to 504 hours (Day 22) after study drug administration
The number of subjects with adverse events
To evaluate the safety and tolerability of a single dose of GLPG1205 administered as capsules fasted versus fed in male healthy subjects in terms of adverse events (AEs)
Time frame: From screening up to 28 (+/-2) days after last study drug administration
The number of subjects with abnormal laboratory parameters
To evaluate the safety and tolerability of a single dose of GLPG1205 administered as capsules fasted versus fed in male healthy subjects in terms of abnormal laboratory parameters
Time frame: From screening up to 28 (+/-2) days after last study drug administration
The number of subjects with abnormal vital signs
To evaluate the safety and tolerability of a single dose of GLPG1205 administered as capsules fasted versus fed in male healthy subjects in terms of abnormal vital signs
Time frame: From screening up to 28 (+/-2) days after last study drug administration
The number of subjects with abnormal electrocardiogram (ECG)
To evaluate the safety and tolerability of a single dose of GLPG1205 administered as capsules fasted versus fed in male healthy subjects in terms of abnormal electrocardiogram (ECG)
Time frame: From screening up to 28 (+/-2) days after last study drug administration
The number of subjects with abnormal physical examination
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To evaluate the safety and tolerability of a single dose of GLPG1205 administered as capsules fasted versus fed in male healthy subjects in terms of abnormal physical examination
Time frame: From screening up to 28 (+/-2) days after last study drug administration