Schizophrenia Clinical Trial
Official title:
A Phase 1, Randomized, Open-label, Single Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Aripiprazole Lauroxil Following Administration to the Deltoid or Gluteal Muscle in Adults With Schizophrenia or Schizoaffective Disorder
Verified date | July 2016 |
Source | Alkermes, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
The study will determine the safety, tolerability, and pharmacokinetics of aripiprazole lauroxil in adults with schizophrenia or schizoaffective disorder.
Status | Completed |
Enrollment | 47 |
Est. completion date | June 2016 |
Est. primary completion date | June 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Has a diagnosis of chronic schizophrenia or schizoaffective disorder - Has demonstrated ability to tolerate aripiprazole - Has been on a stable antipsychotic medication regimen without any changes for at least 2 months prior to screening - Has a body mass index (BMI) of 18.0 to 40.0 kg/m2, inclusive - Additional criteria may apply Exclusion Criteria: - Is pregnant, is planning to become pregnant, or is currently breastfeeding - Has received aripiprazole lauroxil or IM depot aripiprazole within 6 months, or other long-acting, injectable antipsychotic medication within 3 months or currently treated with clozapine - Is a danger to himself/herself at screening or upon admission - Has a history of or positive test result for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C - Has a positive urine drug screen at screening or Day 1 - Additional criteria may apply |
Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Alkermes Investigational Site | Cerritos | California |
United States | Alkermes Investigative Site | Dallas | Texas |
United States | Alkermes Investigational Site | Hoffman Estates | Illinois |
United States | Alkermes Investigational Site | Lemon Grove | California |
United States | Alkermes Investigational Site | Marlton | New Jersey |
United States | Alkermes Investigational Site | Oakland | California |
Lead Sponsor | Collaborator |
---|---|
Alkermes, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maximum plasma concentration (Cmax) | Up to 7 days | No | |
Secondary | Time to Cmax (Tmax) | Up to 7 days | No | |
Secondary | Area under the concentration-time curve from time zero to the last quantifiable time interval (AUCl0-last) | Up to 7 days | No | |
Secondary | Area under the concentration-time curve from time zero to time t (AUC0-t) | Up to 7 days | No | |
Secondary | Terminal elimination half-life (t½) | Up to 7 days | No | |
Secondary | Safety will be determined by incidence of adverse events | Up to 7 days | Yes |
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