Lurasidone Pediatric Pharmacokinetics Study

NCT01620060 ↗

Phase 1 Completed 105 enrolled Sumitomo Pharma America, Inc.

NaSingle-groupOpen-labelTreatment

Summary

This is a Phase 1, open-label, multicenter, single and multiple ascending lurasidone dose study in subjects from 6 to 17 years old with schizophrenia spectrum, bipolar spectrum, autistic spectrum disorder, or other psychiatric disorders.

Timeline

Start: 2012-06
Primary completion: 2013-05
Completion: 2013-05

Publications

Findling RL, Goldman R, Chiu YY, Silva R, Jin F, Pikalov A, Loebel A. Pharmacokinetics and Tolerability of Lurasidone in Children and Adolescents With Psychiatric Disorders. Clin Ther. 2015 Dec 1;37(12):2788-97. doi: 10.1016/j.clinthera.2015.11.001. Epub 2015 Nov 26.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lurasidone	Small molecule	20 mg	Oral
Subject	Lurasidone	Small molecule	40 mg	Oral
Subject	Lurasidone	Small molecule	80 mg	Oral
Subject	Lurasidone	Small molecule	120 mg	Oral
Subject	Lurasidone	Small molecule	160 mg	Oral

Lurasidone Pediatric Pharmacokinetics Study

Summary

Timeline

Publications

Drugs

Indications