Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2017-002294-19 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This clinical study is a Phase I, open-label, single-center study designed to evaluate the pharmacokinetics profile of a single oral dose of GLPG3067 in adult male subjects with cystic fibrosis in fed state.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GLPG3067 single dose. | Experimental | Single Dose of GLPG3067 film coated tablets. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GLPG3067 single dose | Drug | GLPG3067 film coated tablets provided at Day 1. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (cmax) of GLPG3067 single dose. | To evaluate the PK profile of GLPG3067 after a single oral dose of GLPG3067. | Between Day 1 pre-dose and Day 4. |
| Area under the plasma concentration-time curve from time zero until 24 hours post-dose ( (AUC0-24h) of GLPG3067 single dose. | To evaluate the PK profile of GLPG3067 after a single oral dose of GLPG3067. | Between Day 1 pre-dose and Day 4. |
| Area under the plasma concentration-time curve from time zero until 72 hours post-dose (AUC0-72h) of GLPG3067 single dose. | To evaluate the PK profile of GLPG3067 after a single oral dose of GLPG3067. | Between Day 1 pre-dose and Day 4. |
| Measure | Description | Time Frame |
|---|---|---|
| The number of subjects with adverse events. | To evaluate the safety and tolerability of a single oral dose of GLPG3067 in adult male subjects with CF. | From screening to 19 days after the last dose. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Olivier Van de Steen, MD MBA | Lakefront Biotherapeutics NV | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Leuven,Pediatric Pulmonology | Leuven | Belgium |
Not provided
| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |