A Phase 1, Randomized, Open-Label Study Evaluating the Pharmacokinetics of Various Dosing Regimens of Aripiprazole Lauroxil in Subjects With Stable Schizophrenia
Overview
- Phase
- Phase 1
- Intervention
- Aripiprazole Lauroxil
- Conditions
- Schizophrenia
- Sponsor
- Alkermes, Inc.
- Enrollment
- 140
- Locations
- 1
- Primary Endpoint
- T max
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
This study will evaluate the safety, tolerability, and pharmacokinetics (PK) of various doses and dosing intervals of aripiprazole lauroxil.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Has stable 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 35.0 kg/m2, inclusive
- •Additional criteria may apply
Exclusion Criteria
- •Is pregnant, breastfeeding, or is planning to become pregnant during the study period
- •Has received aripiprazole lauroxil or IM depot aripiprazole within 6 months, or other long-acting, injectable antipsychotic medication within 3 months
- •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
Arms & Interventions
Aripiprazole Lauroxil - A
Intramuscular (IM) injection Dose and Dosing Sequence A
Intervention: Aripiprazole Lauroxil
Aripiprazole Lauroxil - B
Intramuscular (IM) injection Dose and Dosing Sequence B
Intervention: Aripiprazole Lauroxil
Aripiprazole Lauroxil - C
Intramuscular (IM) injection Dose and Dosing Sequence C
Intervention: Aripiprazole Lauroxil
Aripiprazole Lauroxil - D
Intramuscular (IM) injection Dose and Dosing Sequence D
Intervention: Aripiprazole Lauroxil
Outcomes
Primary Outcomes
T max
Time Frame: Up to 45 weeks
Time to maximum plasma concentration
AUC 0-last
Time Frame: Up to 45 weeks
Area under the plasma-concentration time curve from time zero to the last quantifiable plasma concentration
C max
Time Frame: Up to 45 weeks
Maximum plasma concentration
Secondary Outcomes
- Safety and tolerability will be measured by incidence of adverse events(Up to 45 weeks)
- AUC 0-tau(Up to 45 weeks)