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This study will evaluate the safety, tolerability, and pharmacokinetics (PK) of various doses and dosing intervals of aripiprazole lauroxil.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aripiprazole Lauroxil - A | Experimental | Intramuscular (IM) injection Dose and Dosing Sequence A |
|
| Aripiprazole Lauroxil - B | Experimental | Intramuscular (IM) injection Dose and Dosing Sequence B |
|
| Aripiprazole Lauroxil - C | Experimental | Intramuscular (IM) injection Dose and Dosing Sequence C |
|
| Aripiprazole Lauroxil - D | Experimental | Intramuscular (IM) injection Dose and Dosing Sequence D |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aripiprazole Lauroxil | Drug | Gluteal IM injection, given once every 4 to 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUC 0-last | Area under the plasma-concentration time curve from time zero to the last quantifiable plasma concentration | Up to 45 weeks |
| C max | Maximum plasma concentration | Up to 45 weeks |
| T max | Time to maximum plasma concentration | Up to 45 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| AUC 0-tau | Area under the plasma-concentration time curve over the dose interval | Up to 45 weeks |
| Safety and tolerability will be measured by incidence of adverse events | Up to 45 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alkermes Medical Director, MD | Alkermes, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alkermes Investigational Site | Little Rock | Arkansas | 72211 | United States | ||
| Alkermes Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28350572 | Result | Hard ML, Mills RJ, Sadler BM, Turncliff RZ, Citrome L. Aripiprazole Lauroxil: Pharmacokinetic Profile of This Long-Acting Injectable Antipsychotic in Persons With Schizophrenia. J Clin Psychopharmacol. 2017 Jun;37(3):289-295. doi: 10.1097/JCP.0000000000000691. | |
| 32621071 | Derived | Weiden PJ, Du Y, von Moltke L, Wehr A, Hard M, Marandi M, Walling DP. Pharmacokinetics, Safety, and Tolerability of a 2-Month Dose Interval Regimen of the Long-Acting Injectable Antipsychotic Aripiprazole Lauroxil: Results From a 44-Week Phase I Study. CNS Drugs. 2020 Sep;34(9):961-972. doi: 10.1007/s40263-020-00745-1. |
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| Cerritos |
| California |
| 90703 |
| United States |
| Alkermes Investigational Site | Garden Grove | California | 92845 | United States |
| Alkermes Investigational Site | Washington D.C. | District of Columbia | 20016 | United States |
| Alkermes Investigational Site | Lauderhill | Florida | 33161 | United States |
| Alkermes Investigational Site | Leesburg | Florida | 34748 | United States |
| Alkermes Investigational Site | Maitland | Florida | 32751 | United States |
| Alkermes Investigational Site | Oakland Park | Florida | 33334 | United States |
| Alkermes Investigational Site | Tampa | Florida | 33613 | United States |
| Alkermes Investigational Site | Atlanta | Georgia | 30308 | United States |
| Alkermes Investigational Site | Chicago | Illinois | 60640 | United States |
| Alkermes Investigational Site | Hoffman Estates | Illinois | 60169 | United States |
| Alkermes Investigational Site | St Louis | Missouri | 63118 | United States |
| Alkermes Investigational Site | Marlton | New Jersey | 8053 | United States |
| Alkermes Investigational Site | Austin | Texas | 78754 | United States |
| Alkermes Investigational Site | Dallas | Texas | 75243 | United States |
| 28597226 | Derived | Hard ML, Mills RJ, Sadler BM, Wehr AY, Weiden PJ, von Moltke L. Pharmacokinetic Profile of a 2-Month Dose Regimen of Aripiprazole Lauroxil: A Phase I Study and a Population Pharmacokinetic Model. CNS Drugs. 2017 Jul;31(7):617-624. doi: 10.1007/s40263-017-0447-7. |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C000603935 | aripiprazole lauroxil |
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