NCT01082146

RI-AME Study OF [ISOTHIAZOLYL-3-14C]-LURASIDONE

A Phase 1 Study to Investigate the Absorption, Metabolism, and Excretion of [Issthiazolyl-3-14C]-Lurasidone Following Postprandial Single Oral Dose Administration in Health Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Sumitomo Pharma America, Inc. · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This will be an open-label, non-randomized, absorption, metabolism, and excretion study of Lurasidone administered in a suspension at 40 mg to 6 normal healthy male subjects in a postprandial state

Detailed description

A Phase 1 Study to Investigate the Absorption, Metabolism, and Excretion of \[Isothiazolyl-3-14C\]-Lurasidone Following Postprandial Single Oral Dose Administration in Healthy Male Subjects.

Conditions

• Pharmacokinetics
• Metabolism

Interventions

Type	Name	Description
DRUG	Lurasidone	40 mg suspension, PO, for 7 days

Timeline

• Start date: 2008-08-01
• Primary completion: 2008-08-01
• Completion: 2008-08-01
• First posted: 2010-03-08
• Last updated: 2014-04-03

Locations

1 site across 1 country: United States