NCT03627195

A Study to Determine the Maximum Tolerated Dose of an Investigational Drug in Subjects With Schizophrenia

A Randomized, Double Blind, Placebo Controlled, Single Ascending Dose Study With Lurasidone Injectable Suspension to Evaluate Safety, Tolerability and Pharmacokinetics in Subjects With Schizophrenia

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Sumitomo Pharma America, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

A study to determine the maximum tolerated dose of an investigational drug in subjects with schizophrenia

Detailed description

This is a single-center, randomized, double-blind, placebo-controlled, inpatient, single ascending dose (SAD) study designed to evaluate the safety, tolerability, and PK of lurasidone injectable suspension in subjects with schizophrenia. This study will determine the minimum intolerable dose (MID), the maximum tolerated dose (MTD) of lurasidone injectable suspension, and characterize the PK profiles of lurasidone and its metabolites in serum (ID-14283, ID-14326, ID-11614, ID-20219, and ID-20220) and urine (ID-14283, ID-14326, and ID-11614) in this subject population. The potential effects of gender on the PK of lurasidone injectable suspension and its metabolites will also be evaluated when applicable.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	DSP-1349M	DSP-1349M injectable
DRUG	placebo	placebo injection

Timeline

• Start date: 2018-06-07
• Primary completion: 2019-03-29
• Completion: 2019-03-29
• First posted: 2018-08-13
• Last updated: 2020-05-08
• Results posted: 2020-05-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study