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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-001718-12 | EudraCT Number |
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The main aim of this study is to investigate the possible effect of GLPG4716 on the pharmacokinetics (PK) of pirfenidone and nintedanib. Further aims are to investigate safety and tolerability of GLPG4716 alone or administered simultaneously with pirfenidone or nintedanib.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GLPG4716 and pirfenidone | Experimental |
| |
| GLPG4716 and nintedanib | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pirfenidone | Drug | On Days 1 and 13, participants will receive an oral dose of pirfenidone. |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) of pirfenidone | To determine the effect of GLPG4716 on the PK of pirfenidone | From Day 1 pre-dose until Day 15 |
| Area under the plasma concentration-time curve from time zero to infinity (AUC0-inf) of pirfenidone | To determine the effect of GLPG4716 on the PK of pirfenidone | From Day 1 pre-dose until Day 15 |
| Cmax of nintedanib | To determine the effect of GLPG4716 on the PK of nintedanib. | From Day 1 pre-dose until Day 15 |
| AUC0-inf of nintedanib | To determine the effect of GLPG4716 on the PK of nintedanib. | From Day 1 pre-dose until Day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 GLPG4716 alone or when co-administered with pirfenidone or nintedanib. | From Day 1 through study completion, an average of 2 months |
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Inclusion Criteria:
This list only includes the key inclusion criteria.
Exclusion Criteria:
This list only includes 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 |
|---|---|---|---|---|---|---|
| Nuvisan GmbH | Neu-Ulm | 89231 | Germany |
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| ID | Term |
|---|---|
| C093844 | pirfenidone |
| C530716 | nintedanib |
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| GLPG4716 | Drug | From Day 3 to Day 14, participants will receive GLPG4716 daily. |
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| Nintedanib | Drug | On Days 1 and 13, participants will receive an oral dose of nintedanib. |
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