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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-002488-23 | EudraCT Number |
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This study is a phase I, randomized, double-blind, placebo-controlled, single-center, to evaluate the safety, tolerability, and pharmacokinetics (PK) of GLPG3667 after an oral single dose (SD) of GLPG3667 (part 1) and after oral multiple doses (MD) for 13 days of GLPG3667 (part 2) in healthy male subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GLPG3667 SD | Experimental | Participants will receive a single dose of GLPG3667 |
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| Placebo SD | Placebo Comparator | Participants will receive a single dose of matching placebo |
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| GLPG3667 MD | Experimental | Participants will receive repeated doses of GLPG3667 for 13 days. |
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| Placebo MD | Placebo Comparator | Participants will receive repeated doses of matching placebo for 13 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GLPG3667 | Drug | GLPG3667 capsules |
| |
| 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 oral doses of GLPG3667, in adult, healthy, male subjects compared with placebo | From screening through study completion, an average of 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) of GLPG3667 - SD | To evaluate the PK of single and multiple oral doses of GLPG3667 in adult, healthy male subjects. | Between Day 1 pre-dose and Day 4 |
| Maximum observed plasma concentration (Cmax) of GLPG3667 - MD |
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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 |
|---|---|---|
| Natalia Rueda-Rincon, MD, PhD | Lakefront Biotherapeutics NV | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Drug Research Unit Ghent | Ghent | 9000 | Belgium |
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| Placebo |
| Drug |
Matching placebo capsules |
|
To evaluate the PK of single and multiple oral doses of GLPG3667 in adult, healthy male subjects. |
| Between Day 1 pre-dose and Day 16 |
| Area under the plasma concentration-time curve (AUC) of GLPG3667 - SD | To evaluate the PK of single and multiple oral doses of GLPG3667 in adult, healthy male subjects. | Between Day 1 pre-dose and Day 4 |
| Area under the plasma concentration-time curve (AUC) of GLPG3667 - MD | To evaluate the PK of single and multiple oral doses of GLPG3667 in adult, healthy male subjects. | Between Day 1 pre-dose and Day 16 |
| Terminal elimination half-life (t1/2) of GLPG3667 - SD | To evaluate the PK of single and multiple oral doses of GLPG3667 in adult, healthy male subjects. | Between Day 1 pre-dose and Day 4 |
| Terminal elimination half-life (t1/2) of GLPG3667 - MD | To evaluate the PK of single and multiple oral doses of GLPG3667 in adult, healthy male subjects. | Between Day 1 pre-dose and Day 16 |