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The purpose of this research study is to assess the safety and tolerability of GLPG1205 in single and multiple oral doses in healthy male Caucasian and Japanese subjects. This study will also assess the pharmacokinetics (PK) across different doses of GLPG1205. PK will look at how the study drug is absorbed, broken down, and eliminated by your body.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GLPG1205 dose A | Experimental | Participants will receive a single dose with dose A of GLPG1205 on Day 1 in Period 1, and 14 days q.d. dosing on Days 1 to 14 in Period 2. |
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| Placebo dose A | Placebo Comparator | Participants will receive a single dose placebo on Day 1 in Period 1, and 14 days q.d. dosing on Days 1 to 14 in Period 2. |
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| GLPG1205 dose B | Experimental | Participants will receive 14 days q.d. dosing with dose B of GLPG1205 on Days 1 to 14. |
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| Placebo dose B | Placebo Comparator | Participants will receive 14 days q.d. dosing placebo on Days 1 to 14. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GLPG1205 | Drug | GLPG1205 film-coated tablets |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency and severity of treatment emergent adverse events (TEAEs), treatment-emergent serious adverse events (SAEs), and TEAEs leading to treatment discontinuation | To evaluate the safety and tolerability of single and multiple oral doses of GLPG1205 in healthy male Japanese and Caucasian subjects | From screening through study completion, an average of 3 months |
| Maximum observed plasma concentration (Cmax) of GLPG1205 | To assess the PK of single and multiple oral doses of GLPG1205 in healthy male Japanese subjects matched with healthy male Caucasian subjects | Between Day 1 pre-dose and Day 18 and at follow-up Day 32 |
| Area under the plasma concentration-time curve from time zero till 24 hours postdose (AUC 0-24h) of GLPG1205 | To assess the PK of single oral doses of GLPG1205 in healthy male Japanese subjects matched with healthy male Caucasian subjects | Between Day 1 pre-dose and Day 18 and at follow-up Day 32 |
| Area under the plasma concentration-time curve over the dosing interval (AUC T) of GLPG1205 | To assess the PK of multiple oral doses of GLPG1205 in healthy male Japanese subjects matched with healthy male Caucasian subjects | Between Day 1 pre-dose and Day 18 and at follow-up Day 32 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ekaterina Tankisheva, MD, PhD | Lakefront Biotherapeutics NV | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| WCCT Global | Cypress | California | 90630 | United States |
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| ID | Term |
|---|---|
| C000722907 | GLPG1205 |
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| Placebo |
| Drug |
placebo film-coated tablets |
|