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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-001803-19 | EudraCT Number |
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The main purpose of this study is to evaluate the safety and tolerability of GLPG3970 in healthy volunteers after single oral administrations of GLPG3970 (SAD), compared to placebo (part 1 and 1bis) and after multiple (for 14 days) oral administrations of GLPG3970 (MAD), compared to placebo (part 2). The effect of food (FE) (high-fat, high calorie) on the pharmacokinetics of GLPG3970 and the relative bioavailability (rBA) of an oral solution versus a solid formulation will be assessed (part 3 and 3bis). Part 4 of the study is to evaluate the safety and tolerability of GLPG3970 in subjects with moderate to severe psoriasis when administered daily for 6 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GLPG3970 SAD | Experimental | Single doses of GLPG3970 at up to 6 dose levels in ascending order |
|
| Placebo SAD | Placebo Comparator | Single doses of placebo |
|
| GLPG3970 MAD | Experimental | Multiple doses of GLPG3970 at up to 4 dose levels in ascending order, daily for 14 days |
|
| Placebo MAD | Placebo Comparator | Multiple doses of placebo |
|
| GLPG3970 FE-rBA | Experimental | Single dose of GLPG3970 in fed and fasted state |
|
| GLPG3970 FE | Experimental | Single dose of GLPG3970 in fed and fasted state |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GLPG3970 oral solution | Drug | GLPG3970 for oral administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of treatment emergent adverse events (TEAEs), treatment-emergent serious adverse events, and TEAEs leading to treatment discontinuations | To evaluate the safety and tolerability of GLPG3970 compared to placebo in adult healthy male subjects as single and multiple ascending oral doses, and in subjects with moderate to severe psoriasis when administered daily for 6 weeks | From screening through study completion, an average of 20 months |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) of GLPG3970 (Part 1 and 1bis) | To evaluate the pharmacokinetics (PK) of oral SAD of GLPG3970 in adult healthy male subjects | Between Day 1 pre-dose and Day 4 |
| Maximum observed plasma concentration (Cmax) of GLPG3970 (Part 2) |
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Inclusion Criteria for Part 1, 1bis, 2, 3 and 3bis:
This list only contains the key inclusion criteria for the healthy volunteers part of the study.
Inclusion criteria for Part 4:
This list only contains the key inclusion criteria for Part 4 of the study.
Exclusion Criteria for Part 1, 1bis, 2, 3 and 3bis:
This list only contains the key exclusion criteria for the healthy volunteers part of the study.
Exclusion criteria for Part 4:
This list only contains the key inclusion criteria for Part 4 of the study.
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| Name | Affiliation | Role |
|---|---|---|
| Magdalena Petkova, MD | Lakefront Biotherapeutics NV | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SGS Belgium NV - Clinical Pharmacology Unit Antwerp | Antwerp | 2060 | Belgium | |||
| Clinical Republican Hospital Arensia Experimental Medicine |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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Part 1 and 1bis (SAD), Part 2 (MAD) and Part 4 (psoriasis subjects) are randomized, double-blind, placebo-controlled; Part 3 (FE-rBA) and Part 3bis (FE) are randomized, open-label.
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|
| GLPG3970 in psoriasis subjects | Experimental |
|
| Placebo in psoriasis subjects | Experimental |
|
| Placebo oral solution | Drug | Placebo for oral administration |
|
| GLPG3970 capsule | Drug | GLPG3970 for oral administration |
|
To evaluate the PK of oral MAD of GLPG3970 in adult healthy male subjects |
| Between Day 1 pre-dose and Day 17 |
| Maximum observed plasma concentration (Cmax) of GLPG3970 (Part 3 and 3bis, FE) | To evaluate the food effect on the PK of a single oral dose of GLPG3970 in adult, healthy, subjects | Between Day 1 pre-dose and Day 4 |
| Maximum observed plasma concentration (Cmax) of GLPG3970 (Part 3, rBA) | To evaluate the PK of a single oral dose of GLPG3970 administered as an oral solution versus and oral capsule in adult, healthy, subjects | Between Day 1 pre-dose and Day 4 |
| Area under curve (AUC) of GLPG3970 (Part 1 and 1bis) | To evaluate the PK of oral SAD of GLPG3970 in adult healthy male subjects | Between Day 1 pre-dose and Day 4 |
| Area under curve (AUC) of GLPG3970 (Part 2) | To evaluate the PK of oral MAD of GLPG3970 in adult healthy male subjects | Between Day 1 pre-dose and Day 17 |
| Area under curve (AUC) of GLPG3970 (Part 3 and 3bis, FE) | To evaluate the food effect on the PK of a single oral dose of GLPG3970 under fed conditions (high-fat high calorie) versus fasted conditions in adult, healthy, subjects | Between Day 1 pre-dose and Day 4 |
| Area under curve (AUC) of GLPG3970 (Part 3, rBA) | To evaluate the rBA of an oral solution of GLPG3970 versus an oral capsule of GLPG3970 on the PK of a single oral dose of GLPG3970 in adult, healthy, subjects | Between Day 1 pre-dose and Day 4 |
| Terminal elimination half-life (t1/2) of GLPG3970 (Part 1 and 1bis) | To evaluate the PK of oral SAD of GLPG3970, in adult, healthy, subjects | Between Day 1 pre-dose and Day 4 |
| Terminal elimination half-life (t1/2) of GLPG3970 (Part 2) | To evaluate the PK of oral MAD of GLPG3970, in adult, healthy, subjects | Between Day 1 pre-dose and Day 17 |
| Chisinau |
| MD2025 |
| Moldova |
| ARENSIA Exploratory Medicine Unit | Kyiv | 01135 | Ukraine |