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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-000449-38 | EudraCT Number |
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This is a single dose, open label study in adult male subjects with cystic fibrosis to investigate the pharmacokinetics, safety and tolerability of GLPG2737.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GLPG2737 single dose. | Experimental | Single dose of GLPG2737 oral suspension. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GLPG2737 single dose | Drug | GLPG2737 oral suspension, single dose |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) of GLPG2737and its metabolite. | To characterize the PK of GLPG2737 and its metabolite after a single oral dose in CF subjects. | Between day 1 pre-dose and 48 hours post-dose. |
| Time of occurrence of Cmax for GLPG2737(tmax) | To determine PK parameters of GLPG2737 and its metabolite after given a single oral dose in CF subjects. | Between day 1 pre-dose and 48 hours post-dose. |
| Plasma concentration observed at 24 hours post-dos (C24h) | To assess PK parameters of GLPG2737 and its metabolite after given a single oral dose in CF subjects. | Between day 1 pre-dose and 48 hours post-dose. |
| Area under the plasma concentration-time curve for GLPG2737 (AUC0-24h) | To determine the PK of GLPG2737 and its metabolite after a single oral dose in CF subjects. | Between day 1 pre-dose and 48 hours post-dose. |
| Area under the plasma concentration-time curve from time zero until 48 hours post-dose (AUC0-48h) | To determine the PK of GLPG2737 and its metabolite after a single oral dose in CF subjects. | Between day 1 pre-dose and 48 hours post-dose. |
| Terminal plasma elimination rate constant (ke) | To determine the PK of GLPG2737 and its metabolite after a single oral dose in CF subjects. | Between day 1 pre-dose and 48 hours post-dose. |
| Apparent terminal elimination half-life ( t1/2) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with adverse events. | To determine the safety and tolerability of GLPG2737 after a single oral dose in CF subjects. | Between screening and 15 days post-dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Olivier Van de Steen, MD MBA | Lakefront Biotherapeutics NV | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ KU Leuven | Leuven | Belgium |
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| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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To determine the PK of GLPG2737 and its metabolite after a single oral dose in CF subjects. |
| Between day 1 pre-dose and 48 hours post-dose. |
| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |