Digoxin Drug-Drug Interaction With Lurasidone HCl

Sumitomo Pharma

Status and phase: Completed; Phase 1

Conditions: Schizophrenia

Treatments: Drug: Lurasidone

Study type: Interventional

Funder types: Industry

Identifiers

NCT01082289

D1050279

Details and patient eligibility

About

The objective of this study is to evaluate the pharmacokinetic profile of digoxin when administered alone and when administered with repeated dose of lurasidone 120mg.

Enrollment: 24 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and female 18 to 65 years of age
• BMI >= 19.5 and <= 37 kg/m2
• No clinically relevant abnormal laboratory values

Exclusion criteria

• History or presence of renal or hepatic insufficiency
• Participated in a clinical trial in the past 30 days
• Use of con meds that prolong the QT/QTc taken within 28 days prior to study drug administration