This study is a Phase I, single-center, randomized, double-blind, placebo-controlled study to evaluate the effect of aging on safety, tolerability and PK of multiple oral doses of GLPG1205 in healthy male subjects. The study will comprise of 2 parts, a first part to investigate the effect of aging and a second part to investigate the effect of a loading dose.
In Part 1, a total of 24 healthy male subjects matched for weight will be divided into 3 age groups: * Cohort A: 8 subjects aged 65 to 74 years, inclusive * Cohort B: 8 subjects aged ≥ 75 years (1:1 weight matched with subjects of Cohort A \[±5 kg\]) * Cohort C: 8 subjects aged between 18-50 years, inclusive (1:1 weight matched with subjects of Cohort A \[±5 kg\]) Each cohort will be randomized 3:1 to active (6 subjects) and placebo (2 subjects) treatment respectively. Weight matched subjects in Cohorts B and C will be assigned to active treatment and placebo accordingly. Cohorts A and C will be dosed with 50 mg q.d. GLPG1205 for 14 days. In the open-label Part 2, an additional cohort of 8 subjects aged 65-74 years (Cohort D) will be included to characterize the PK profile after a loading dose followed by multiple doses of GLPG1205 q.d. for 13 days. A 250 mg loading dose will be administered on Day 1 followed by 50 mg q.d. from Day 2 to Day 14.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
32
oral gelatin capsule containing 50mg GLPG1205 for q.d. administration - compared to placebo
oral gelatin capsule containing placebo to match study arm 1 - q.d. administration
Open label - oral gelatin capsule containing 50mg GLPG1205 for one time 250mg loading dose and subsequent q.d. administration
SGS clinical pharmacology unit
Antwerp, Belgium
Difference between the number of healthy male subjects from different age groups and placebo subjects with adverse events
to assess safety and tolerability in the first placebo controlled part of the study
Time frame: From screening until the final follow up visit (day 35)
Difference between the number of healthy male subjects from different age groups and placebo subjects with abnormal laboratory evaluations
to assess safety and tolerability in the first placebo controlled part of the study
Time frame: From screening until the final follow up visit (day 35)
Difference between the number of healthy male subjects from different age groups and placebo subjects with abnormal vital signs
to assess safety and tolerability in the first placebo controlled part of the study
Time frame: From screening until the final follow up visit (day 35)
Difference between the number of healthy male subjects from different age groups and placebo subjects with abnormal ECG
to assess safety and tolerability in the first placebo controlled part of the study
Time frame: From screening until the final follow up visit (day 35)
Difference between the number of healthy male subjects from different age groups and placebo subjects with abnormal physical examination
to assess safety and tolerability in the first placebo controlled part of the study
Time frame: From screening until the final follow up visit (day 35)
Difference between healthy male subjects of different age groups of Cmax of GLPG1205
To assess PK of GLPG1205 in the first part of the study with different age groups
Time frame: From day 1 pre-dose until the final follow up visit (day 35)
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Difference between healthy male subjects of different age groups of tmax of GLPG1205
To assess PK of GLPG1205 in the first part of the study with different age groups
Time frame: From day 1 pre-dose until the final follow up visit (day 35)
Difference between healthy male subjects of different age groups of AUC0-t of GLPG1205
To assess PK of GLPG1205 in the first part of the study with different age groups
Time frame: From day 1 pre-dose until the final follow up visit (day 35)
Difference between healthy male subjects of different age groups of apparent terminal half-life (t1/2) of GLPG1205
To assess PK of GLPG1205 in the first part of the study with different age groups
Time frame: From day 1 pre-dose until the final follow up visit (day 35)
Assessment of Cmax of GLPG1205 in subjects having received a loading dose of 250mg and subsequent 50mg q.d. maintenance dose
In the open label (part 2) of the study
Time frame: From day 1 pre-dose until the final follow up visit (day 35)
Assessment of tmax of GLPG1205 in subjects having received a loading dose of 250mg and subsequent 50mg q.d. maintenance dose
In the open label (part 2) of the study
Time frame: From day 1 pre-dose until the final follow up visit (day 35)
Assessment of AUC0-t of GLPG1205 in subjects having received a loading dose of 250mg and subsequent 50mg q.d. maintenance dose
In the open label (part 2) of the study
Time frame: From day 1 pre-dose until the final follow up visit (day 35)
Assessment of t1/2 of GLPG1205 in subjects having received a loading dose of 250mg and subsequent 50mg q.d. maintenance dose
In the open label (part 2) of the study
Time frame: From day 1 pre-dose until the final follow up visit (day 35)
Assessment of creatinine clearance in healthy elderly subjects
To assess renal function in healthy elderly subjects
Time frame: From screening until the final follow up visit (day 35)