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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-004022-28 | EudraCT Number |
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| Name | Class |
|---|---|
| Syndesi Therapeutics | INDUSTRY |
| KU Leuven | OTHER |
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This is a First-in-Human, Randomized, Placebo-controlled, Single Ascending Oral Dose Study of SDI-118 in Healthy Male Subjects including Receptor Occupancy Measurements after Single Dose of SDI-118 and an Assessment of Food Effect.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SDI-118 Dose 1 | Experimental |
| |
| SDI-118 Dose 2 | Experimental |
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| SDI-118 Dose 3 | Experimental |
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| SDI-118 Dose 4 | Experimental |
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| SDI-118 Dose 5 | Experimental |
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| SDI-118 Dose 6 | Experimental |
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| SDI-118 Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SDI-118 | Drug | SDI-118 Powder in Capsule |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Adverse Events (AEs) | Adverse events (AEs) will be coded using medical dictionary for regulatory activities (MedDRA). An AE is any untoward medical occurrence in a participant administered a study drug and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medical product whether or not considered related to the medical product. An AE is considered "serious" if, in the view of either the investigator or sponsor, the event: results in death, is life-threatening, results in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, results in congenital anomaly or birth defect, requires hospitalization or prolongation to hospitalization, or other medically important event. | 21 Days |
| Number of participants with laboratory value abnormalities and/or adverse events (AEs) | Number of participants with potentially clinically significant laboratory values (hematology/chemistry/urinalysis) | 21 Days |
| Number of participants with vital sign abnormalities and/or adverse events (AEs) | Number of participants with potentially clinically significant vital sign values | 21 Days |
| Number of participants with temperature abnormalities and/or adverse events (AEs) | Number of participants with potentially clinically significant temperature values | 21 Days |
| Number of participants with routine 12 lead electrocardiogram (ECG) abnormalities and/or Adverse Events (AEs) | Number of participants with potentially clinically significant ECG values. |
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Inclusion Criteria:
Specifically, Part B/PET related inclusion criteria:
Specifically, Part C/FE related inclusion criteria:
Exclusion Criteria:
Any of the following findings in the resting ECG:
Specifically, Part B/PET related exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jan deHoon, MD | UZ Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Clinical Pharmacology, UZ Leuven | Leuven | B-3000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36733374 | Derived | Botermans W, Koole M, Van Laere K, Savidge JR, Kemp JA, Sunaert S, Duffy MM, Ramael S, Cesura AM, D'Ostilio K, Gossen D, Madsen TM, Lodeweyckx T, de Hoon J. SDI-118, a novel procognitive SV2A modulator: First-in-human randomized controlled trial including PET/fMRI assessment of target engagement. Front Pharmacol. 2023 Jan 17;13:1066447. doi: 10.3389/fphar.2022.1066447. eCollection 2022. |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| Placebo | Drug | Matching Placebo |
|
| 21 Days |
| Number of participants with routine physical examination abnormalities and/or Adverse Events (AEs) | Number of participants with potentially clinically significant changes in physical examination. | 21 Days |
| Number of participants with routine neurological examination abnormalities and/or Adverse Events (AEs) | Number of participants with potentially clinically significant changes in neurological examination. | 21 Days |
| Number of participants with abnormalities on Profile of Mood States (Brief) and/or Adverse Events (AEs) | Number of participants with potentially clinically significant changes in Profile of Mood States (Brief) values. | 21 Days |
| Number of participants with abnormalities on Bond-Lader-VAS and/or Adverse Events (AEs) | Number of participants with potentially clinically significant changes in Bond-Lader VAS values. | 21 Days |