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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-004252-30 | EudraCT Number |
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This study aims to evaluate the safety, tolerabilty, pharmacokinetics and pharmacodynamics of single ascending doses and multiple ascending doses of APX-115 in healthy males. This study also aims to evaluate the effect of food consumption on the pharmacokinetics of APX-115 and potential interaction between caffeine and APX-115 in healthy males.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SAD: APX-115 | Experimental | Experimental: APX-115 SAD group |
|
| SAD: Placebo | Placebo Comparator | Experimental: Placebo group |
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| MAD: APX-115 | Experimental | Experimental: APX-115 MAD group |
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| MAD: Placebo | Placebo Comparator | Experimental: Placebo group |
|
| Food effect - Fasting condition | Active Comparator | Experimental: APX-115 under fasting condition |
|
| Food effect - fed condition | Active Comparator | Experimental: APX-115 under fed condition |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SAD: APX-115 | Drug | Drug: APX-115 SAD APX-115 SAD for 1day |
| |
| Measure | Description | Time Frame |
|---|---|---|
| SAD: incidence of treatment emergent adverse events | Up to Day 8 | |
| SAD: number of clinically significant abnormal findings from vital signs (blood pressure, pulse) | Up to Day 8 | |
| SAD: number of clinically significant abnormal findings from physical exam | Up to Day 8 | |
| SAD: number of clinically significant abnormal findings from electrocardiogram | Up to Day 8 | |
| SAD: number of clinically significant abnormal findings from biological tests | Up to Day 8 | |
| MAD: incidence of treatment emergent adverse events | Up to Day 17 | |
| MAD: number of clinically significant abnormal findings from vital signs (blood pressure, pulse) | Up to Day 17 | |
| MAD: number of clinically significant abnormal findings from physical exams | Up to Day 17 | |
| MAD: number of clinically significant abnormal findings from electrocardiogram | Up to Day 17 | |
| Food effect: peak serum concentration (Cmax) of APX-115 under fasting and fed conditions | Up to Day 4 post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| SAD: time to reach Cmax (Tmax) of APX-115 | Up to Day 5 | |
| SAD: peak serum concentration (Cmax) of APX-115 | Up to Day 5 | |
| SAD: lowest plasma concentration before next dosing (Ctrough) |
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Inclusion:
Exclusion:
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| Name | Affiliation | Role |
|---|---|---|
| Yves Donazzolo, MD | Eurofins Optimed | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eurofins Optimed | Gières | 38610 | France |
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| ID | Term |
|---|---|
| C000620865 | isuzinaxib |
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Parallel design for SAD and MAD studies Crossover design for Food and Drug interaction studies
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| Drug Interaction - metabolic probe | Placebo Comparator | Experimental: metabolic probe |
|
| SAD: Placebo |
| Drug |
Drug: Placebo Placebo for 1day |
|
| MAD: APX-115 | Drug | Drug: APX-115 MAD APX-115 MAD repeatedly administered. |
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| MAD: Placebo | Drug | Matching study drug will be repeatedly administered. |
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| Food effect: fasted and fed | Other | A single dose of APX-115, selected from the SAD study, will be administered under fasted and fed condition. |
|
| Metabolic probe with or without APX-115 | Other | A metabolic probe will be administered with and without APX-115. |
|
| Food effect: time to reach the Cmax (Tmax) of APX-115 under fasting and fed conditions | Up to Day 4 post-dose |
| Food effect: area under the curve (AUC) of APX-115 under fasting and fed conditions | Up to Day 4 post-dose |
| Food effect: elimination rate constant (Kel) of APX-115 under fasting and fed conditions | Up to Day 4 post-dose |
| Food effect: ratio AUCfed/AUCfasted | Up to Day 4 post-dose |
| Drug interaction: peak serum concentration (Cmax) of a metabolic probe or APX-115 | Up to Day 4 post-dose |
| Drug interaction: Time to reach the Cmax (tmax) of a metabolic probe or APX-115 | Up to Day 4 post-dose |
| Drug interaction study: Area under the Curve (AUC) of a metabolic probe or APX-115 | Up to Day 4 post-dose |
| Drug interaction: elimination rate constant (Kel) of a metabolic probe or APX-115 | Up to Day 4 post-dose |
| Drug interaction: half-life (t1/2) of a metabolic probe or APX-115 | Up to Day 4 post-dose |
| Drug interaction: volume of distribution (Vd/f) of a metabolic probe or APX-115 | Up to Day 4 post-dose |
| Drug interaction: clearance of a metabolic probe or APX-115 | Up to Day 4 post-dose |
| Drug interaction: Incidences of treatment emergent adverse events | Up to Day 4 post-dose |
| Up to Day 5 |
| SAD: Area Under the Curve (AUC) of APX-115 | Up to Day 5 |
| SAD: volume of distribution (Vd/F) of APX-115 | Up to Day 5 |
| SAD: clearance (CL/F) of APX-115 | Up to Day 5 |
| MAD: peak serum concentration (Cmax) of APX-115 | Up to Day 11 |
| MAD: time to reach the Cmax (Tmax) of APX-115 | Up to Day 11 |
| MAD: Area Under the Curve (AUC) of APX-115 | Up to Day 11 |
| MAD: lowest plasma concentration of APX-115 before next dosing (Ctrough) | Up to Day 11 |
| MAD: volume of distribution (Vd/F) of APX-115 | Up to Day 11 |
| MAD: Clearance (CL/F) of APX-115 | Up to Day 11 |
| MAD: accumulation ratio | Up to Day 11 |
| Food effect & drug interaction: incidence of treatment emergent adverse events | Up to Day 4 post-dose |
| Food effect & drug interaction: number of clinically significant findings from vital signs (blood pressure and pulse) | Up to Day 4 post-dose |
| Food effect & drug interaction: number of clinically significant findings from physical exam | Up to Day 4 post-dose |
| Food effect & drug interaction: number of clinically significant findings from electrocardiogram | Up to Day 4 post-dose |
| Food effect & drug interaction: number of clinically significant findings from biological tests | Up to Day 4 post-dose |