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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-003997-34 | EudraCT Number |
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This is a study to assess the relative bioavailability of a GLPG3970 oral tablet formulation compared to an oral solution formulation and the effect of food on the bioavailability of a single dose of the oral tablet formulation of GLPG3970. It will also evaluate the safety and tolerability of a single dose of GLPG3970.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GLPG3970 solution | Experimental | Single oral dose of GLPG3970 in fasted conditions |
|
| GLPG3970 tablet fasted | Experimental | Single oral dose of GLPG3970 in fasted conditions |
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| GLPG3970 tablet fed | Experimental | Single oral dose of GLPG3970 in fed conditions |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GLPG3970 oral solution | Drug | GLPG3970 for oral administration |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) of GLPG3970 | To assess the bioavailability (BA) of a GLPG3970 oral tablet formulation (test) relative to that of an oral solution formulation (reference). To assess the effect of food on BA of a single oral dose of the oral tablet formulation of GLPG3970. | Between Day 1 pre-dose and Day 4 |
| Area under the plasma concentration-time curve from time zero to infinity (AUC0-inf) | To assess the BA of a GLPG3970 oral tablet formulation (test) relative to that of an oral solution formulation (reference). To assess the effect of food on BA of a single oral dose of the oral tablet formulation of GLPG3970. | Between Day 1 pre-dose and Day 4 |
| Area under the plasma concentration-time curve from time zero until the last observed quantifiable concentration (AUC0-t) | To assess the BA of a GLPG3970 oral tablet formulation (test) relative to that of an oral solution formulation (reference). To assess the effect of food on BA of a single oral dose of the oral tablet formulation of GLPG3970. | Between Day 1 pre-dose and Day 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Treatment-emergent Adverse Events (TEAEs) by Severity | To evaluate the safety and tolerability of a single dose of GLPG3970. | From Day 1 through study completion, an average of 1 month |
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Inclusion Criteria:
This list only contains the key inclusion criteria.
Exclusion Criteria:
This list only contains the key exclusion criterion.
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| Name | Affiliation | Role |
|---|---|---|
| Ekaterina Tankisheva, MD | Lakefront Biotherapeutics NV | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Biotral Rennes | Rennes | 35042 | France |
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| GLPG3970 tablet |
| Drug |
GLPG3970 for oral administration |
|