An Open-Label Study of Aripiprazole Lauroxil in Subjects With Stable Schizophrenia

Summary

This study will evaluate the safety, tolerability, and pharmacokinetics (PK) of various doses and dosing intervals of aripiprazole lauroxil.

Timeline

Start

2014-12

Primary completion

2016-04

Completion

2016-04

Publications

• Results 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.
• 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.
• 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.

Drugs

Indications