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| ID | Type | Description | Link |
|---|---|---|---|
| INDIGO-APS-1001 | Other Identifier | Janssen Research & Development, LLC | |
| 2011-006133-41 | EudraCT Number |
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The purpose of this study is to compare capillary (the smallest of a body's blood vessels) and venous whole blood and plasma concentrations of 5 antipsychotics after given of a single oral, immediate-release dose to healthy participants.
This is a randomized (the study drug is assigned by chance), open-label (all people know the identity of the intervention), parallel-group (each group of patients will be treated at the same time), single-center study. Participants will be randomly assigned to 1 of 5 cohorts (groups) defined by the antipsychotic drug (aripiprazole, quetiapine, olanzapine, risperidone or paliperidone). Antipsychotics are drugs that are helpful in the treatment of psychosis and have a capacity to ameliorate thought disorders. Participants will enter the investigational site in the morning of Day -1 and stay until the morning of Day 2. Participants will return to the study site for subsequent assessments as per study's schedule. The total study length for a participant is approximately 26 days, except for participants receiving aripiprazole for whom the total study length is approximately 39 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A: Aripiprazole | Experimental |
| |
| Cohort B: Quetiapine | Experimental |
| |
| Cohort C: Olanzapine | Experimental |
| |
| Cohort D: Risperidone | Experimental |
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| Cohort E: Paliperidone | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aripiprazole | Drug | Type= exact number, unit= mg, number= 5, form= tablet, route= oral administration. A single oral dose of a 5-mg aripiprazole tablet will be administered after an overnight fast. |
| Measure | Description | Time Frame |
|---|---|---|
| Aripiprazole concentration in venous and capillary plasma, venous and capillary whole blood | 16 time points over 408 hours postdose | |
| Quetiapine concentration in venous and capillary plasma, venous and capillary whole blood | 12 time points over 108 hours postdose | |
| Olanzapine concentration in venous and capillary plasma, venous and capillary whole blood | 12 time points over 108 hours postdose | |
| Risperidone concentration in venous and capillary plasma, venous and capillary whole blood | 12 time points over 108 hours postdose | |
| Paliperidone concentration in venous and capillary plasma, venous and capillary whole blood | 12 time points over 108 hours postdose | |
| Dehydroaripiprazole concentration in venous and capillary plasma, venous and capillary whole blood | 16 time points over 408 hours postdose | |
| 9 hydroxy-risperidone concentration in venous and capillary plasma, venous and capillary whole blood | 12 time points over 108 hours postdose |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events as a measure of safety and tolerability | Approximately 26 days (Cohorts B, C, D, E), and approximately 39 days (Cohort A) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Merksem | Belgium |
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| ID | Term |
|---|---|
| D000068180 | Aripiprazole |
| D000069348 | Quetiapine Fumarate |
| D000077152 | Olanzapine |
| D018967 | Risperidone |
| D000068882 | Paliperidone Palmitate |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D015363 | Quinolones |
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| Quetiapine | Drug | Type= exact number, unit= mg, number= 100, form= tablet, route= oral administration. A single oral dose of two 50-mg quetiapine tablets will be administered after an overnight fast. |
|
| Olanzapine | Drug | Type= exact number, unit= mg, number= 5, form= tablet, route= oral administration. A single oral dose of a 5-mg olanzapine tablet will be administered after an overnight fast. |
|
| Risperidone | Drug | Type= exact number, unit= mg, number= 1, form= tablet, route= oral administration. A single oral dose of a 1-mg risperidone tablet will be administered after an overnight fast. |
|
| Paliperidone | Drug | Type= exact number, unit= mg, number= 3, form= tablet, route= oral administration. A single oral dose of a 3-mg paliperidone tablet will be administered after an overnight fast. |
|
| D011804 |
| Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003987 | Dibenzothiazepines |
| D013841 | Thiazepines |
| D013846 | Thiepins |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D007555 | Isoxazoles |
| D001393 | Azoles |