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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GLPG1205 50mg q.d. | Experimental | oral hard gelatin capsules with 50 mg GLPG1205 for q.d. administration - compared to placebo |
|
| placebo | Placebo Comparator | oral hard gelatin capsules containing placebo for q.d. administration |
|
| GLPG1205 250 mg loading and 50mg q.d. maintenance | Experimental | open label - oral hard gelatin capsules with 50 mg GLPG1205 for one time 250 mg loading dose and subsequent 50mg q.d. administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GLPG1205 50mg q.d. | Drug | oral gelatin capsule containing 50mg GLPG1205 for q.d. administration - compared to placebo |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 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 | 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 | 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of creatinine clearance in healthy elderly subjects | To assess renal function in healthy elderly subjects | From screening until the final follow up visit (day 35) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Helen Timis, MBChB MICR | Lakefront Biotherapeutics NV | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SGS clinical pharmacology unit | Antwerp | Belgium |
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| ID | Term |
|---|---|
| C000722907 | GLPG1205 |
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| Placebo oral capsule | Drug | oral gelatin capsule containing placebo to match study arm 1 - q.d. administration |
|
| GLPG1205 250 loading dose and 50mg q.d. maintenance dose | Drug | Open label - oral gelatin capsule containing 50mg GLPG1205 for one time 250mg loading dose and subsequent q.d. administration |
|
| From day 1 pre-dose until the final follow up visit (day 35) |
| 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 | 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 | 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 | 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 | 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 | 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 | 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 | From day 1 pre-dose until the final follow up visit (day 35) |