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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-004357-16 | EudraCT Number |
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The sponsor wants to investigate how well the test medicine is taken up by the body when given alongside two other already approved medicines. This kind of study is known as a drug-drug interaction study. In this case the other medicines are itraconazole and voriconazole.
The sponsor will also look at the safety and tolerability of the test medicine when taken alone, and when taken with the approved medicines.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Experimental | single dose GLPG1690. |
|
| Treatment B | Experimental | Single dose itraconazole + single dose GLPG1690. |
|
| Treatment C | Experimental | Single dose voriconazole + single dose GLPG1690. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GLPG1690 | Drug | A single oral dose of GLPG1690. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration of GLPG1690 (Cmax). | To investigate the effect of a single oral dose of itraconazole or voriconazole on the single-dose pharmacokinetics of GLPG1690 in healthy male subjects. | At various time points between Day 1 pre-dose and Day 5 |
| Area under the plasma concentration-time curve from time zero to infinity of GLPG1690 (AUC0-∞). | To investigate the effect of a single oral dose of itraconazole or voriconazole on the single-dose pharmacokinetics of GLPG1690 in healthy male subjects. | At various time points between Day 1 pre-dose and Day 5 |
| Apparent terminal half-life of GLPG1690 (t1/2,λz). | To investigate the effect of a single oral dose of itraconazole or voriconazole on the single-dose pharmacokinetics of GLPG1690 in healthy male subjects. | At various time points between Day 1 pre-dose and Day 5 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of incidents of TEAEs. | To assess safety and tolerability of GLPG1690. | Between screening and 10 days after the last dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher Brearley, BM, MRCP, MFPM | Lakefront Biotherapeutics NV | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quotient Sciences Limited | Ruddington | United Kingdom |
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| Itraconazole | Drug | A single oral dose of itraconazole. |
|
| Voriconazole | Drug | A single oral dose of voriconazole. |
|
| ID | Term |
|---|---|
| C000621178 | GLPG1690 |
| D017964 | Itraconazole |
| D065819 | Voriconazole |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010879 | Piperazines |
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