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The main purpose of this study is to determine the effect of itraconazole on the amount of GLPG3667 that gets into the blood when the 2 drugs are administered together compared to when GLPG3667 is administered alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GLPG3667 + itraconazole | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GLPG3667 | Drug | On day 1 and day 8, participants will receive a single dose |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) of GLPG3667 | To determine the effect of itraconazole on the pharmacokinetics (PK) of GLPG3667 | From Day 1 pre-dose until Day 12 |
| Area under the plasma concentration-time curve from time zero to infinity (AUC0-inf) of GLPG3667 | To determine the effect of itraconazole on the PK of GLPG3667 | From Day 1 pre-dose until Day 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (SAEs), and TEAEs leading to treatment discontinuation. | To evaluate the safety and tolerability of GLPG3667 alone or when co-administered with itraconazole | From Day 1 through study completion, an average of 2 months |
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Inclusion Criteria:
This list only contains the key inclusion criteria.
Exclusion Criteria:
This list only contains the key exclusion criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Galapagos Study Director, MD | Lakefront Biotherapeutics NV | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Altasciences | Montreal | QC H3P 3P1 | Canada |
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| ID | Term |
|---|---|
| D017964 | Itraconazole |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Itraconazole |
| Drug |
On days 5 to 11, participants will receive itraconazole once daily |
|
| D010879 |
| Piperazines |