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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-001659-38 | EudraCT Number |
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This study is a first-in-human, Phase I, randomized, double-blind, placebo-controlled, single-center, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics of GLPG3667 after oral single ascending doses (SAD) of GLPG3667 (part 1) and after oral multiple ascending doses (MAD) for 13 days of GLPG3667 (part 2) in healthy male subjects. In addition, the effect of food (FE) on safety, tolerability, and PK of GLPG3667 oral suspension will be evaluated (part 3 - will not be completed), and the relative bioavailability (rBA) of the capsule versus the oral suspension with the effect of food on the bioavailability of the capsule (part 4), both part 3 and 4 using an open-label, randomized, crossover design.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GLPG3667 SAD | Experimental | Single doses of GLPG3667 at up to 6 dose levels in ascending order |
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| Placebo SAD | Placebo Comparator | Single doses of placebo |
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| GLPG3667 MAD | Experimental | Multiple doses of GLPG3667 at up to 3 dose levels in ascending order, daily for 13 days |
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| Placebo MAD | Placebo Comparator | Multiple doses of placebo |
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| GLPG3667 FE fasted | Experimental | Single dose of GLPG3667 in fasted state |
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| GLPG3667 FE fed | Experimental | Single dose of GLPG3667 in fed state |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GLPG3667 oral suspension | Drug | GLPG3667 oral suspension |
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| 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 GLPG3667, in adult, healthy, male subjects compared with placebo | From screening through study completion, an average of 5 months |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) of GLPG3667 (μg/mL) | To evaluate the pharmacokinetics (PK) of single and multiple ascending oral doses of GLPG3667, in adult, healthy, male subjects | Between Day 1 pre-dose and Day 16 |
| Area under curve (AUC) of GLPG3667 (μg.h/mL) |
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Inclusion Criteria:
Exclusion Criteria:
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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 |
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| GLPG3667 oral suspension rBA-FE fed | Experimental | Single dose of GLPG3667 oral suspension in fed state |
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| GLPG3667 capsules rBA-FE fasted | Experimental | Single dose of GLPG3667 capsules in fasted state |
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| GLPG3667 capsules rBA-FE fed | Experimental | Single dose of GLPG3667 capsules in fed state |
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| Placebos | Drug | Placebo oral suspension |
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| GLPG3667 capsules | Drug | GLPG3667 capsules |
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To evaluate the PK of single and multiple ascending 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 (h) | To evaluate the PK of single and multiple ascending oral doses of GLPG3667, in adult, healthy, male subjects | Between Day 1 pre-dose and Day 16 |