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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-000892-16 | 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 GLPG0778 given to healthy subjects for 13 days compared to placebo, and to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0778 after multiple oral administrations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GLPG0778 ascending doses | Experimental | Multiple ascending doses for 13 days, ranging from 50 mg twice daily upto a maximum to be determined during escalation. |
|
| Placebo | Placebo Comparator | Twice daily for 13 days, matching the scheme of the multiple ascending dose. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GLPG0778 | Drug | capsules containing 50 or 100 mg of GLPG0778 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of adverse events | At every study visit, subjects will be asked whether any adverse events have occurred since start of treatment. | Daily during treatment, up to 10 days postdose |
| Evaluation of hematological, biochemical and cardiovascular parameters. | On predefined timepoints during the study blood and urine samples will be taken, and cardiovascular tests (ECG, blood pressure, heart rate) recorded to assess whether the test compound causes any deviation. | until 10 days postdose. |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of repeated doses | Bloodsamples are taken on various timepoints to assess how much of the study drug is taken up in the blood (absorption), how long it stays in the blood (excretion), and whether any "breakdown"-products of the drug are present (metabolism). | 24 hours postdose |
| Pharmacodynamics (PD) of GLPG0778 |
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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 |
| Lien Gheyle, MD | SGS Stuivenberg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SGS Stuivenberg | Antwerp | Belgium |
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| placebo |
| Drug |
multiple dose, aqueous formulation, 13 days days, matching ascending dose schedule |
|
To explore biomarkers of GLPG0778 activity after repeated oral administrations. |
| up to 10 days postdose |