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| Name | Class |
|---|---|
| PRA Health Sciences | INDUSTRY |
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This is an open-label study to determine the pharmacokinetics of a new tablet formulation of GLPG1972 and to compare it with this of the liquid solution used during the First-in-Human study (GLPG1972-CL-101). The impact of food intake on the oral bioavailability of GLPG1972 administered as tablet will also be investigated in this study. A dose of 600 mg has been selected. The study is a phase I randomized open-label cross-over study with three single dose treatments:
A) 600 mg GLPG1972 oral solution after overnight fast,
B) 600 mg GLPG1972 oral tablet after overnight fast,
C) 600 mg GLPG1972 oral tablet 30 minutes after high-fat high-calorie breakfast.
A washout of at least 6 days between subsequent dosing days is respected so that no measurable plasma levels or biologically significant effects are remaining. There will be frequent assessment of adverse experiences post-dose. Twelve healthy male subjects will be selected according to the inclusion and exclusion criteria and 2 subjects each will be randomized to one of the 6 treatment sequences (ABC, ACB, BAC, BCA, CAB, CBA)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GLPG1972 600 mg oral solution fasted | Experimental | 600 mg GLPG1972 administered as oral solution after overnight fasting |
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| GLPG1972 600 mg oral tablet fasted | Experimental | 600 mg GLPG1972 administered as oral tablet after overnight fasting |
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| GLPG1972 600 mg oral tablet fed | Experimental | 600 mg GLPG1972 administered as oral tablet after a high-fat high-calorie breakfast |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GLPG1972 600 mg oral solution fasted | Drug | dosing after overnight fasting |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) of GLPG1972 | To study the pharmacokinetics of 600 mg GLPG1972 administered as oral liquid solution or as oral tablet after overnight fasting or administered as oral tablet after a high-fat high calorie breakfast | From pre-dose (period 1) until 6 days after the last dose (period 3) |
| Plasma concentration of GLPG1972 24 hours after dosing | To study the pharmacokinetics of 600 mg GLPG1972 administered as oral liquid solution or as oral tablet after overnight fasting or administered as oral tablet after a high-fat high calorie breakfast | 24 hours after each dose |
| The time of the occurrence of Cmax of GLPG1972 | To study the pharmacokinetics of 600 mg GLPG1972 administered as oral liquid solution or as oral tablet after overnight fasting or administered as oral tablet after a high-fat high calorie breakfast | From pre-dose (period 1) until 6 days after the last dose (period 3) |
| The area under the plasma concentration versus time curve | To study the pharmacokinetics of 600 mg GLPG1972 administered as oral liquid solution or as oral tablet after overnight fasting or administered as oral tablet after a high-fat high calorie breakfast | From pre-dose until 6 days post-dose for each dosing period |
| The apparent terminal half-life of GLPG1972 | To study the pharmacokinetics of 600 mg GLPG1972 administered as oral liquid solution or as oral tablet after overnight fasting or administered as oral tablet after a high-fat high calorie breakfast | From pre-dose (period 1) until 6 days after the last dose (period 3) |
| The number of adverse events reported |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ennis Lee, MD | Lakefront Biotherapeutics NV | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PRA-EDS | Zuidlaren | Netherlands |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| GLPG1972 600 mg oral tablet fasted | Drug | dosing after overnight fasting |
|
| GLPG1972 600 mg oral tablet fed | Drug | dosing after high-fat high-calorie breakfast |
|
To evaluate safety and tolerability of single oral doses of GLPG1972 |
| From pre-dose until the Follow up (FU) visit anticipated to take place 7-10 days after the last dose |
| Changes in clinical laboratory evaluations | To evaluate safety and tolerability of single oral doses of GLPG1972 | From pre-dose until the Follow up (FU) visit anticipated to take place 7-10 days after the last dose |
| Changes in vital signs | To evaluate safety and tolerability of single oral doses of GLPG1972 | From pre-dose until the Follow up (FU) visit anticipated to take place 7-10 days after the last dose |
| Changes in physical examination parameters | To evaluate safety and tolerability of single oral doses of GLPG1972 | From pre-dose until the Follow up (FU) visit anticipated to take place 7-10 days after the last dose |
| Changes in ECG parameters | To evaluate safety and tolerability of single oral doses of GLPG1972 | From pre-dose until the Follow up (FU) visit anticipated to take place 7-10 days after the last dose |