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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-002144-25 | EudraCT Number |
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The sponsor wants to investigate two new tablet formulations (recipes) of the test medicine, and how they are taken up by the body in comparison to the current tablet formulation (study periods 1 to 3). If one of the 2 new tablets has a more favourable profile than the current tablet in periods 1 to 3, the sponsor will then investigate the effect that food has on this new tablet in study period 4. However, if the new tablets do not have a more favourable profile than the current tablet, the food effect does not need to be investigated and study period 4 will not be needed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tablet A | Experimental | A single oral 300-mg dose of GLPG1972 in fasted state |
|
| Tablet B | Experimental | A single oral 300-mg dose of GLPG1972 in fasted state |
|
| Tablet C | Experimental | A single oral 300-mg dose of GLPG1972 in fasted state |
|
| Food effect | Experimental | selected tablet B or C under fed conditions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GLPG1972 - A | Drug | Film-coated tablet, formulation A |
| |
| GLPG1972 - B |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration-time curve from time zero until the time corresponding with the last observed quantifiable concentration calculated by the linear up (AUC0-t) ratio between tablet formulations | To assess the bioavailability of two candidate tablet formulations (Tablet B and Tablet C) relative to that of the current tablet formulation (Tablet A) of GLPG1972 | From Day 1 pre-dose up to Day 4 |
| Area under the plasma concentration-time curve from time zero to infinity (AUC0-∞) ratio between tablet formulations | To assess the bioavailability of two candidate tablet formulations (Tablet B and Tablet C) relative to that of the current tablet formulation (Tablet A) of GLPG1972 | From Day 1 pre-dose up to Day 4 |
| Maximum observed plasma concentration (Cmax) ratio between tablet formulations | To assess the food effect of the selected Phase 3 tablet formulation (in case Tablet B or Tablet C) of GLPG1972 | From Day 1 pre-dose up to Day 4 |
| Area under the plasma concentration-time curve from time zero until the time corresponding with the last observed quantifiable concentration calculated by the linear up (AUC0-t) ratio between fed and fasted | To assess the food effect of the selected Phase 3 tablet formulation (in case Tablet B or Tablet C) of GLPG1972 | From Day 1 pre-dose up to Day 4 |
| Area under the plasma concentration-time curve from time zero to infinity (AUC0-∞) ratio between fed and fasted | To assess the food effect of the selected Phase 3 tablet formulation (in case Tablet B or Tablet C) of GLPG1972 | From Day 1 pre-dose up to Day 4 |
| Maximum observed plasma concentration (Cmax) ratio between fed and fasted |
| Measure | Description | Time Frame |
|---|---|---|
| The number of incidents of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (SAEs) and TEAEs leading to discontinuations | To evaluate the safety and tolerability of oral doses of GLPG1972 tablet formulations | From Day 1 through study completion, an average of 2 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Angela de Haas-Amatsaleh, MD | Lakefront Biotherapeutics NV | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quotient Sciences Limited | Nottingham | NG11 6JS | United Kingdom |
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| Drug |
Film-coated tablet, formulation B |
|
| GLPG1972 - C | Drug | Film-coated tablet, formulation C |
|
To assess the bioavailability of two candidate tablet formulations (Tablet B and Tablet C) relative to that of the current tablet formulation (Tablet A) of GLPG1972 |
| From Day 1 pre-dose up to Day 4 |