NCT04030143

A Trial of Multiple-doses of Aripiprazole in Adults With Schizophrenia or Bipolar 1 Disorder

A Phase 1b, Open-label, Multiple-dose, Randomized, Parallel-arm, Safety, Tolerability, and Pharmacokinetic Trial of Aripiprazole Intramuscular Depot Administered in the Gluteal Muscle in Adult Subjects With Schizophrenia or Bipolar I Disorder

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 266 (actual)
• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this trial is to determine the safety and tolerability of multiple-dose administrations of aripiprazole, to establish the similarity of aripiprazole concentrations on the last day of the dosing interval following the final administration of aripiprazole into the gluteal muscle site, and to establish the similarity of aripiprazole exposure over the dosing interval following the administration of aripiprazole into the gluteal muscle site in adult participants with schizophrenia or bipolar I disorder.

Conditions

• Schizophrenia
• Bipolar I Disorder

Interventions

Type	Name	Description
DRUG	Aripiprazole	Administered as an intramuscular (IM) depot injection.
DRUG	Aripiprazole	Administered as an IM depot injection.

Timeline

• Start date: 2019-08-01
• Primary completion: 2020-07-08
• Completion: 2020-07-08
• First posted: 2019-07-23
• Last updated: 2023-11-18
• Results posted: 2023-11-18

Locations

19 sites across 1 country: United States

Regulatory

• FDA-regulated drug study