Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2010-023199-16 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of the study is to evaluate the safety and tolerability of single ascending (SAD) and multiple (MD) oral doses of GLPG0778 compared to placebo (with and without food).
Also, pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0778 after single and multiple oral administration will be evaluated, and, if applicable, the maximum tolerated dose determined.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | single ascending doses |
|
| 2 | Placebo Comparator | single dose placebo |
|
| 3 | Experimental | multiple dose, 7 days, capsules (dosing depends on outcome of single-dose part; can be once or twice daily). |
|
| 4 | Placebo Comparator | multiple dose, capsules, 7 days; scheme to match that of Study Arm 3. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GLPG0778 | Drug | single ascending doses, oral solution (10 to 800 mg/dose) and capsules (100 mg/dose) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of single and multiple dosing | Tests will be performed to assess whether the study drug has any potentially adverse effect (laboratory tests on blood and urine for functioning of organs; cardiovascular testing, i.e. of heart and bloodcirculation). Also, participants will carefully be monitored by medical staff for vital signs, and asked to report any side effect experienced in the course of the study. | up to 10 days postdose |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of single and repeated doses, including effect of food. | 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). | up to 10 days postdose |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 | 2060 | Belgium |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| placebo |
| Drug |
single dose, oral solution or capsule (matching corresponding study medication) |
|
| GLPG0778 | Drug | multiple dose, capsule, 7 days |
|
| placebo | Drug | multiple dose, capsule, 7 days |
|