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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-018570-20 | EudraCT Number |
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The purpose of the study is to evaluate the safety and tolerability of multiple ascending oral doses (MAD) of GLPG0555 given to healthy subjects for 13 days compared to placebo, and to evaluate the relative bioavailability and pharmacokinetics (PK) of two different aqueous suspensions of GLPG0555 administered for 3 days. Finally, it is aimed to characterize PK and pharmacodynamics (PD) of GLPG0555 after multiple oral administrations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aqueous formulations for formulation selection | Experimental | 50 mg once daily for 3 days of two different aqueous suspensions, with four day wash-out between formulation |
|
| GLPG0555 ascending doses | Experimental | multiple ascending doses for 13 days, ranging from 100 mg once daily upto a maximum to be determined during escalation (given as once or twice daily) |
|
| 3 | Placebo Comparator | once or twice daily for 13 days, matching the scheme of the multiple ascending dose. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GLPG0555 | Drug | two different aqueous formulations |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of multiple dosing | Daily during treatment, up to 10 days postdose |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of repeated doses | 24 hours postdose | |
| Pharmacodynamics (PD) of GLPG0555 after repeated oral administration | up to 10 days postdose | |
| The relative bioavailability and pharmacokinetics (PK) of two different aqueous suspensions administered for three days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gerben van 't Klooster, PhD | Lakefront Biotherapeutics NV | Study Director |
| Wouter Haazen, MD | SGS Stuivenberg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SGS Stuivenberg | Antwerp | Belgium |
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| GLPG0555 aqueous |
| Drug |
multiple dose, aqueous formulation, 13 days, 100 mg/day once daily, maximum dose to be determined |
|
| placebo | Drug | multiple dose, aqueous formulation, 13 days days, matching ascending dose schedule |
|
| up to 24 hours postdose |