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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-004846-12 | EudraCT Number |
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A study in healthy volunteers to look at the effect of the test medicine, GLPG3667, on how midazolam (MDZ) is taken up and eliminated by the body.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GLPG3667 + Midazolam | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GLPG3667 | Drug | From Day 3 to Day 8, GLPG3667 capsules q.d. orally in fed state. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration-time curve from time zero to infinity (AUC0-inf) of MDZ | To determine the effect of GLPG3667 on the pharmacokinetics (PK) of MDZ. | From Day 1 until Day 9 |
| Maximum observed plasma concentration (Cmax) of MDZ | To determine the effect of GLPG3667 on the PK of MDZ. | From Day 1 until Day 9 |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of GLPG3667 | To evaluate the PK of GLPG3667 in the presence of a single dose of MDZ. | From Day 3 until Day 8 |
| Area under the plasma concentration-time curve over the dosing interval (AUCÏ„) for GLPG3667 |
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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 |
|---|---|---|
| Natalia Rueda-Rincon, MD | Lakefront Biotherapeutics NV | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quotient Sciences | Nottingham | NG11 6JS | United Kingdom |
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| ID | Term |
|---|---|
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Midazolam |
| Drug |
On Day 1 and Day 7 as liquid formulation, orally in fed state. |
|
To evaluate the PK of GLPG3667 in the presence of a single dose of MDZ.
| From Day 3 until Day 8 |
| Trough plasma concentration observed (Ct) for GLPG3667 | To evaluate the PK of GLPG3667 in the presence of a single dose of MDZ. | From Day 3 until Day 8 |
| Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (SAEs), and TEAEs leading to treatment discontinuations. | To evaluate the safety and tolerability of GLPG3667 alone or when coadministered with MDZ. | From Day 1 through study completion, an average of 3 weeks |
| D006571 | Heterocyclic Compounds |