Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1UG3DA047699-02 | U.S. NIH Grant/Contract | ||
| 1UG3DA047699 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
Not provided
Not provided
Not provided
Not provided
The study will be conducted as a single-center, randomized, double-blind, placebo-controlled, ascending dose study in up to 4 sequential cohorts of healthy subjects. Each cohort will enroll 8 subjects: 6 subjects will receive ITI-333 and 2 subjects will receive placebo once daily for 14 days.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: 0.75 mg ITI-333 or placebo once daily for 14 days | Experimental |
| |
| Cohort 2: 1.5 mg ITI-333 or placebo once daily for 14 days | Experimental |
| |
| Cohort 3: 3 mg ITI-333 or placebo once daily for 14 days | Experimental |
| |
| Cohort 4: 6 mg ITI-333 or placebo once daily for 14 days | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ITI-333 | Drug | ITI-333 oral solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: AUC0-tau | Area under the plasma drug concentration-time curve (AUC) from time zero to the end of dosing interval | Day 14: predose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 h postdose |
| Pharmacokinetics: Cmax | Maximum plasma concentration of ITI-333 over a dosing interval | Day 14: predose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 h postdose |
| Pharmacokinetics: Tmax | Time of maximum plasma concentration of ITI-333 over a dosing interval | Day 14: predose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 h postdose |
| Percentage of Subjects With Treatment-emergent Adverse Events | up to 30 days after last dose | |
| Change From Baseline in Systolic and Diastolic Blood Pressure | Baseline and Day 17 | |
| Change From Baseline in SpO2 | Baseline and Day 17 | |
| Change From Baseline in ECG QTcF Interval | Baseline and Day 17 | |
| Change From Baseline in Aspartate Aminotransferase | Baseline and Day 17 | |
| Change From Baseline in Alanine Aminotransferase |
Not provided
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Site 1 | Miami | Florida | 33014-3616 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 0.75 mg ITI-333 | 0.75 mg ITI-333 oral solution once daily for 14 days |
| FG001 | 1.5 mg ITI-333 | 1.5 mg ITI-333 oral solution once daily for 14 days |
| FG002 | 3 mg ITI-333 | 3 mg ITI-333 oral solution once daily for 14 days |
| FG003 | 6 mg ITI-333 | 6 mg ITI-333 oral solution once daily for 14 days |
| FG004 | Pooled Placebo | Matching placebo once daily for 14 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 0.75 mg ITI-333 | 0.75 mg ITI-333 oral solution once daily for 14 days |
| BG001 | 1.5 mg ITI-333 | 1.5 mg ITI-333 oral solution once daily for 14 days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pharmacokinetics: AUC0-tau | Area under the plasma drug concentration-time curve (AUC) from time zero to the end of dosing interval | The PK Population included all subjects who had at least one evaluable estimate of a PK parameter. | Posted | Mean | Standard Deviation | h*ng/mL | Day 14: predose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 h postdose |
|
Up to 30 days after the last dose
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 0.75 mg ITI-333 | 0.75 mg ITI-333 oral solution once daily for 14 days | 0 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Non-systematic Assessment | Treatment-Emergent Adverse Event |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| ITI Clinical Trials | Intra-Cellular Therapies, Inc. | 6464409333 | ITCIClinicalTrials@itci-inc.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 6, 2023 | Mar 11, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 13, 2023 | Mar 11, 2026 | SAP_001.pdf |
Not provided
Sequential ascending doses. Parallel (active, placebo) within each cohort
Not provided
Not provided
Not provided
| Placebo | Other | Matching placebo |
|
| Baseline and Day 17 |
| BG002 | 3 mg ITI-333 | 3 mg ITI-333 oral solution once daily for 14 days |
| BG003 | 6 mg ITI-333 | 6 mg ITI-333 oral solution once daily for 14 days |
| BG004 | Pooled Placebo | Matching placebo once daily for 14 days |
| BG005 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| 3 mg ITI-333 |
3 mg ITI-333 oral solution once daily for 14 days |
| OG003 | 6 mg ITI-333 | 6 mg ITI-333 oral solution once daily for 14 days |
|
|
| Primary | Pharmacokinetics: Cmax | Maximum plasma concentration of ITI-333 over a dosing interval | The PK Population included all subjects who had at least one evaluable estimate of a PK parameter. | Posted | Mean | Standard Deviation | ng/mL | Day 14: predose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 h postdose |
|
|
|
| Primary | Pharmacokinetics: Tmax | Time of maximum plasma concentration of ITI-333 over a dosing interval | The PK Population included all subjects who had at least one evaluable estimate of a PK parameter. | Posted | Median | Full Range | h | Day 14: predose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 h postdose |
|
|
|
| Primary | Percentage of Subjects With Treatment-emergent Adverse Events | Subjects who received at least one dose of study drug were included in the analysis population. | Posted | Count of Participants | Participants | up to 30 days after last dose |
|
|
|
| Primary | Change From Baseline in Systolic and Diastolic Blood Pressure | Subjects having both baseline and Day 17 blood pressure measurements were included in the analysis population. | Posted | Mean | Standard Deviation | mmHg | Baseline and Day 17 |
|
|
|
| Primary | Change From Baseline in SpO2 | Subjects having both baseline and Day 17 SpO2 measurements were included in the analysis population. | Posted | Mean | Standard Deviation | % (percentage of oxygen saturation) | Baseline and Day 17 |
|
|
|
| Primary | Change From Baseline in ECG QTcF Interval | Subjects having both baseline and Day 17 QTcF measurements were included in the analysis population. | Posted | Mean | Standard Deviation | msec | Baseline and Day 17 |
|
|
|
| Primary | Change From Baseline in Aspartate Aminotransferase | Subjects having both baseline and Day 17 AST measurements were included in the analysis population. | Posted | Mean | Standard Deviation | U/L | Baseline and Day 17 |
|
|
|
| Primary | Change From Baseline in Alanine Aminotransferase | Subjects having both baseline and Day 17 ALT measurements were included in the analysis population. | Posted | Mean | Standard Deviation | U/L | Baseline and Day 17 |
|
|
|
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | 1.5 mg ITI-333 | 1.5 mg ITI-333 oral solution once daily for 14 days | 0 | 6 | 0 | 6 | 1 | 6 |
| EG002 | 3 mg ITI-333 | 3 mg ITI-333 oral solution once daily for 14 days | 0 | 6 | 0 | 6 | 4 | 6 |
| EG003 | 6 mg ITI-333 | 6 mg ITI-333 oral solution once daily for 14 days | 0 | 6 | 0 | 6 | 2 | 6 |
| EG004 | Pooled Placebo | Matching placebo once daily for 14 days | 0 | 8 | 0 | 8 | 4 | 8 |
|
| Somnolence | Nervous system disorders | Non-systematic Assessment | Treatment-Emergent Adverse Event |
|
| Dizziness | Nervous system disorders | Non-systematic Assessment | Treatment-Emergent Adverse Event |
|
| Alanine aminotransferase increased | Investigations | Non-systematic Assessment | Treatment-Emergent Adverse Event |
|
| C-reactive protein increased | Investigations | Non-systematic Assessment | Treatment-emergent adverse event |
|
| Blood creatine phosphokinase increased | Investigations | Non-systematic Assessment | Treatment-emergent adverse event |
|
| Red blood cell sedimentation rate increased | Investigations | Non-systematic Assessment | Treatment-emergent adverse event |
|
| Back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Treatment-emergent adverse event |
|
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Treatment-emergent adverse event |
|
| Pruritus | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Treatment-emergent adverse event |
|
| Rash maculo-papular | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Treatment-emergent adverse event |
|
| Anxiety | Psychiatric disorders | Non-systematic Assessment | Treatment-emergent adverse event |
|
Not provided
Not provided
| Diastolic Blood Pressure |
|