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| Name | Class |
|---|---|
| H. Lundbeck A/S | INDUSTRY |
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This trial will determine the Pharmacokinetics, safety and tolerability of single-dose Aripiprazole administered intramuscularly in adults with schizophrenia
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Aripiprazole; single; gluteal |
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| Cohort 2 | Experimental | Aripiprazole; single; gluteal |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aripiprazole | Drug | Injection |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events (AEs) [safety and tolerability] | AEs will be monitored to assess safety and tolerability of drug | Screening Days -30 to Day 182 post dose/Early Termination |
| Clinical Laboratory Tests [safety and tolerability] | Hematology, clinical chemistry & urinalysis tests will be performed to assess the safety and tolerability of drug. | Screening Days -30 to Day 182 post dose/Early Termination |
| Electrocardiograms (ECGs) [Safety and tolerability] | Heart rate, RR, PR, WRS and WT intervals will be monitored to assess the safety and tolerability of the drug. | Screening Days -30 to Day 182 post dose/Early Termination |
| Vital Signs [safety and tolerability] | Systolic/diastolic blood pressure, heart rate and body temperature will be monitored to assess the safety and tolerability of the drug. | Screening Days -30 to Day 182 post dose/Early Termination |
| Suicidality via Columbia-Suicide Severity Rating Scale (C-SSRS) [safety and tolerability] | C-SSRS score will be monitored throughout the trial to assess the safety and tolerability of drug | Screening Days -30 to Day 182 post dose/Early Termination |
| Extrapyramidal Symptoms (EPS) Rating Scales | EPS score will be monitored to assess safety and tolerability of drug | Screening Days -30 to Day 182 post dose/Early Termination |
| Investigator's Assessment of Injection Site |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics - Maximum plasma concentration (Cmax) | The maximum plasma concentration of drug at injection site will be assessed for plasma Aripiprazole and its major metabolite dehydro-aripiprazole | Day 1 to Day 182/Early Termination |
| Pharmacokinetics - time of maximum plasma concentration (tmax) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Woodland International Research Group | Little Rock | Arkansas | 72211 | United States | ||
| CNRI-San Diego |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000068180 | Aripiprazole |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D015363 | Quinolones |
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The injection site will be monitored to assess the safety and tolerability of drug |
| Screening Days -30 to Day 182 post dose/Early Termination |
| Visual Analog Scale (VAS) Scores for Pain Perception | VAS score will be monitored to assess safety and tolerability of drug | Day 1 to Day 28 post dose |
The amount of time that the maximum plasma concentration of drug at injection site will be assessed for plasma Aripiprazole and its major metabolite dehydro-aripiprazole |
| Day 1 to Day 182/Early Termination |
| Pharmacokinetics - area under concentration-time curve (AUC) calculated from time zero to time t (AUCt) | AUCt will be assessed for plasma Aripiprazole and its major metabolite dehydro-aripiprazole to determine average concentration of drug over time | Day 1 to Day 182/Early Termination |
| Pharmacokinetics - AUC calculated from time to infinity | AUCinfinity will be assessed for plasma Aripiprazole and its major metabolite dehydro-aripiprazole to determine total drug exposure over time | Day 1 to Day 182/Early Termination |
| Pharmacokinetics - Terminal-phase elimination half-life (t1/2,z) | t1/2,z will be assessed for plasma Aripiprazole and its major metabolite dehydro-aripiprazole to determine drug persistence in the body | Day 1 to Day 182/Early Termination |
| San Diego |
| California |
| 92102 |
| United States |
| Community Clinical Research Inc. | Austin | Texas | 78754 | United States |
| D011804 |
| Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |