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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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This is an open-label, single-dose study of up to 4 dose levels of ITI-333 in healthy male and female subjects. Each cohort will enroll 6 subjects. Subjects will have a baseline PET/CT scan and a postdose PET/CT scan using [14C]-MDL100907 to characterize 5-HT2A receptor occupancy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A1: ITI-333 2.25 mg | Experimental |
| |
| Cohort A2: ITI-333 dose to be determined based on Cohort A1 | Experimental |
| |
| Cohort A3: ITI-333 dose to be determined based on Cohort A1 and A2 | Experimental |
| |
| Cohort A4: ITI-333 dose to be determined based on Cohort A1, A2 and A3 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ITI-333 | Drug | ITI-333 oral solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacodynamics: 5-HT2A receptor occupancy (RO) using [11C]-MDL100907 | baseline 90-minute PET scan between Day -10 and Day -1, and a 90-minute PET scan starting at approximately 1 hour postdose | |
| Pharmacokinetics: AUC0-t | Area under the plasma concentration time curve from time zero to the last measurable of concentration of ITI-333 | predose and multiple timepoints up to 24 hours postdose |
| Pharmacokinetics: Cmax | Maximum observed plasma concentration | predose and multiple timepoints up to 24 hours postdose |
| Pharmacokinetics: Tmax | Time to reach maximum observed plasma concentration | predose and multiple timepoints up to 24 hours postdose |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects with treatment-emergent adverse events | up to 30 days after last dose | |
| Change from baseline in systolic and diastolic blood pressure | Up to Day 7 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Site 2 | Creve Coeur | Missouri | 63141 | United States | ||
| Clinical Site 1 |
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| Change from baseline in ECG QT interval |
| Up to Day 7 |
| Change from baseline in aspartate aminotransferase | Up to Day 7 |
| Change from baseline in alanine aminotransferase | Up to Day 7 |
| St Louis |
| Missouri |
| 63110 |
| United States |