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The study is a First-in-Human, Phase I, randomized, double-blind, placebo-controlled, single center study, evaluating single and multiple ascending oral doses of GLPG3067 and the combination of GLPG3067 and GLPG2222 and the combination of GLPG3067,GLPG2222 and GLPG2737 given for 14 days in healthy women of non-childbearing potential.
The purpose of the study is to evaluate the safety and tolerability of single ascending oral doses and multiple ascending oral doses of GLPG3067 given to healthy women of non-childbearing potential compared to placebo, as well as of multiple oral doses of the combination of GLPG3067/GLPG2222 compared to matching placebo for each compound and multiple oral doses of the combination of GLPG3067/GLPG2222/GLPG2737 compared to matching placebo for each compound.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GLPG3067 single dose | Experimental | Single dose of GLPG3067 oral suspension at up to 6 dose levels in ascending order. |
|
| Placebo single dose | Placebo Comparator | Single dose of Placebo oral suspension. |
|
| GLPG3067 oral suspension fed 1 | Experimental | Single dose 1 of GLPG3067 oral suspension after a standardized breakfast. |
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| GLPG3067 oral tablet fed 1 | Experimental | Single dose 1 of GLPG3067 oral tablet after a standardized breakfast. |
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| GLPG3067 oral tablet fasted 1 | Experimental | Single dose 1 of GLPG3067 oral tablet after an overnight fast. |
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| GLPG3067 oral tablet fed 2 | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GLPG3067 single dose | Drug | GLPG3067 oral suspension, single ascending doses, daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change versus placebo in the proportion of subjects with adverse events | To assess safety and tolerability of single ascending doses, multiple ascending doses of GLPG3067 alone, or in combination with GLPG2222, or in combination with GLPG2222 and GLPG2737 versus placebo in healthy subjects | Between screening and 14 days after the last dose |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration of GLPG3067 (Cmax) given alone or in combination with GLPG2222 or in combination with GLPG2222 and GLPG2737 | To characterize pharmacokinetics of GLPG3067 after a single oral dose and of GLPG3067, GLPG2222, and GLPG2737 after multiple oral doses in healthy subjects | Between Day 1 predose and 10 days after the last dose |
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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 LSS Clinical Pharmacology Unit Antwerp | Antwerp | Belgium |
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Single dose 2 of GLPG3067 oral tablet after a standardized breakfast.
|
| GLPG3067 oral tablet fed 2 high-fat high-calorie | Experimental | Single dose 2 of GLPG3067 oral tablet after a high-fat high-calorie breakfast |
|
| GLPG3067 multiple dose | Experimental | Multiple doses of GLPG3067 oral suspension at up to 5 dose levels in ascending order. |
|
| Placebo multiple dose | Placebo Comparator | Multiple doses of Placebo oral suspension. |
|
| GLPG3067/GLPG2222 multiple dose | Experimental | Multiple doses of GLPG3067 oral suspension combined with GLPG2222 oral tablet up to 2 dose levels in ascending order. |
|
| GLPG3067/GLPG2222 Placebo multiple dose | Placebo Comparator | Multiple doses of GLPG3067 matching placebo oral suspension combined with GLPG2222 matching placebo oral tablet. |
|
| GLPG3067/GLPG2222/GLPG2737 multiple dose | Experimental | Multiple doses of GLPG3067 oral tablet combined with GLPG2222 oral tablet and GLPG2737 oral capsule at up to 2 dose levels in ascending order. |
|
| GLPG3067/GLPG2222/GLPG2737 Placebo multiple dose | Placebo Comparator | Multiple doses of GLPG3067 matching placebo oral tablet combined with GLPG2222 matching placebo oral tablet and GLPG2737 matching placebo oral capsule. |
|
| Placebo single dose |
| Drug |
Placebo, oral suspension, daily |
|
| GLPG3067 multiple dose | Drug | GLPG3067 oral suspension, multiple ascending doses, daily for 14 days |
|
| Placebo multiple dose | Drug | Placebo, oral suspension, daily for 14 days |
|
| GLPG3067 oral suspension | Drug | GLPG3067 oral suspension, single dose, daily |
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| GLPG3067 oral tablet | Drug | GLPG3067 oral tablet, single dose, daily |
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| GLPG3067/GLPG2222 multiple dose | Drug | GLPG3067 oral suspension and GLPG2222 oral tablet, multiple doses, daily for 14 days |
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| GLPG3067/GLPG2222 Placebo multiple dose | Drug | GLPG3067 matching placebo oral suspension and GLPG2222 matching placebo oral tablet, multiple doses, daily for 14 days |
|
| GLPG3067/GLPG2222/GLPG2737 multiple dose | Drug | GLPG3067 oral tablet, GLPG2222 oral tablet and GLPG2737 oral capsule, multiple doses, daily for 14 days |
|
| GLPG3067/GLPG2222/GLPG2737 Placebo multiple dose | Drug | GLPG3067 matching placebo oral tablet, GLPG2222 matching placebo oral tablet and GLPG2737 matching placebo oral capsule, multiple doses, daily for 14 days |
|
| Area under the plasma concentration-time curve of GLPG3067 (AUC0-t) given alone or in combination with GLPG2222 or in combination with GLPG2222 and GLPG2737 | To characterize pharmacokinetics of GLPG3067 after a single oral dose and of GLPG3067, GLPG2222, and GLPG2737 after multiple oral doses in healthy subjects | Between Day 1 predose and 10 days after the last dose |
| Ratio of 4-beta-hydroxycholesterol/cholesterol in plasma after multiple oral doses in healthy subjects | To assess the potential for CYP3A4 interaction with GLPG3067, GLPG3067 and GLPG2222, or GLPG3067 and GLPG2222 and GLPG2737 | Day 1 predose and Day 14 |
| Maximum observed plasma concentration of GLPG3067 (Cmax) given alone in fed state | To assess the relative bioavailability of GLPG3067 when given as a single dose of oral suspension or an oral tablet both administered in fed state | Between Day 1 predose and 10 days after the last dose |
| Concentration in plasma observed at 24 hours post dose (C24h) of GLPG3067 given alone in fed state | To assess the relative bioavailability of GLPG3067 when given as a single dose of oral suspension or an oral tablet both administered in fed state | Between Day 1 predose and 10 days after the last dose |
| Area under the plasma concentration-time curve of GLPG3067 (AUC0-t) given alone in fed state | To assess the relative bioavailability of GLPG3067 when given as a single dose of oral suspension or an oral tablet both administered in fed state | Between Day 1 predose and 10 days after the last dose |
| Maximum observed plasma concentration of GLPG3067 (Cmax) given alone in fasted state | To assess the effect of food on the pharmacokinetics of GLPG3067 when given under fasted versus fed conditions | Between Day 1 predose and 10 days after the last dose |
| Concentration in plasma observed at 24 hours post dose (C24h) of GLPG3067 given alone in fasted state | To assess the effect of food on the pharmacokinetics of GLPG3067 when given under fasted versus fed conditions | Between Day 1 predose and 10 days after the last dose |
| Area under the plasma concentration-time curve of GLPG3067 (AUC0-t) given alone in fasted state | To assess the effect of food on the pharmacokinetics of GLPG3067 when given under fasted versus fed conditions | Between Day 1 predose and 10 days after the last dose |