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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-004174-21 | EudraCT Number |
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The aim of the study is to examine the safety and tolerability of GLPG3121-modified release formulation when given to healthy male subjects once as a single dose or multiple times over a period of 14 days in fasting condition or after a standard breakfast.
The study will evaluate how the body absorbs and breaks down GLPG3121, and how GLPG3121 and the major breakdown product of GLPG3121 are eliminated from the body. In addition, the study will investigate the effect of food (high-fat) after a single oral dose of GLPG3121 as modified release tablet.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GLPG3121 SAD | Experimental | Single doses of GLPG3121 at up to 3 dose levels in ascending order |
|
| Placebo SAD | Placebo Comparator | Single doses of placebo |
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| GLPG3121 MAD | Experimental | Multiple doses of GLPG3121 at up to 3 dose levels in ascending order |
|
| Placebo MAD | Placebo Comparator | Multiple doses of placebo |
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| GLPG3121 FE fed | Experimental | Single dose of GLPG3121 in fed state |
|
| GLPG3121 FE fasted | Experimental | Single dose of GLPG3121 in fasted state |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GLPG3121 | Drug | GLPG3121 modified-release tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Frequency and severity of treatment emergent adverse events (TEAEs), treatment-emergent serious adverse events, and TEAEs leading to treatment discontinuations | To evaluate the safety and tolerability of single and multiple ascending oral doses of GLPG3121-modified-release formulation (GLPG3121-MR), in adult, healthy, male subjects compared with placebo | From screening through study completion, an average of 8 months |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) of GLPG3121 in SAD | To evaluate the pharmacokinetics (PK) of single ascending oral doses of GLPG3121 in adult, healthy, male subjects | Between Day 1 pre-dose and Day 6 |
| Cmax of GLPG3121's main metabolite in SAD |
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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 |
|---|---|---|
| Magdalena Petkova, MD | Lakefront Biotherapeutics NV | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charité Research Organisation GmbH | Berlin | 10117 | Germany |
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Part 1 Single Ascending Dose (SAD) and Part 2 Multiple Ascending Dose (MAD) are randomized, double-blind, placebo-controlled; Part 3 Food-effect (FE) is randomized, open-label, crossover
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| Placebo | Drug | Matching placebo |
|
To evaluate the PK of single ascending oral doses of GLPG3121's metabolite in adult, healthy, male subjects |
| Between Day 1 pre-dose and Day 6 |
| Cmax of GLPG3121 in MAD | To evaluate the PK of multiple ascending oral doses of GLPG3121 in adult, healthy, male subjects | Between Day 1 pre-dose and Day 19 |
| Cmax of GLPG3121's main metabolite in MAD | To evaluate the PK of multiple ascending oral doses of GLPG3121's main metabolite in adult, healthy, male subjects | Between Day 1 pre-dose and Day 19 |
| Area under the plasma concentration-time curve (AUC) of GLPG3121 in SAD | To evaluate the PK of single ascending oral doses of GLPG3121 in adult, healthy, male subjects | Between Day 1 pre-dose and Day 6 |
| AUC of GLPG3121's main metabolite in SAD | To evaluate the PK of single ascending oral doses of GLPG3121's main metabolite in adult, healthy, male subjects | Between Day 1 pre-dose and Day 6 |
| AUC of GLPG3121 in MAD | To evaluate the PK of multiple ascending oral doses of GLPG3121 metabolite in adult, healthy, male subjects | Between Day 1 pre-dose and Day 19 |
| AUC of GLPG3121's main metabolite in MAD | To evaluate the PK of multiple ascending oral doses of GLPG3121's main metabolite in adult, healthy, male subjects | Between Day 1 pre-dose and Day 19 |
| Terminal elimination half-life (t1/2) of GLPG3121 in SAD | To evaluate the PK of single ascending oral doses of GLPG3121 in adult, healthy, male subjects | Between Day 1 pre-dose and Day 6 |
| t1/2 of GLPG3121's main metabolite in SAD | To evaluate the PK of single ascending oral doses of GLPG3121's main metabolite in adult, healthy, male subjects | Between Day 1 pre-dose and Day 6 |
| t1/2 of GLPG3121 in MAD | To evaluate the PK of multiple ascending oral doses of GLPG3121 in adult, healthy, male subjects | Between Day 1 pre-dose and Day 19 |
| t1/2 of GLPG3121's main metabolite in MAD | To evaluate the PK of multiple ascending oral doses of GLPG3121's main metabolite in adult, healthy, male subjects | Between Day 1 pre-dose and Day 19 |