Digoxin Drug-Drug Interaction With Lurasidone HCl

A Phase 1, Open-Label, Drug-Drug Interaction Study to Determine the Effect of Repeated Dose Lurasidone 120 mg Administration on the Pharmacokinetics of Orally Administered Digoxin 0.25 mg in Patients With Schizophrenia or Schizoaffective Disorder.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01082289

Enrollment

Registered

2010-03-08

Start date

2008-09-30

Completion date

2008-10-31

Last updated

2011-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Keywords

Lurasidone, Schizophrenia, Latuda

Brief summary

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.

Interventions

DRUGLurasidone

Study design

Allocation

Intervention model

SINGLE_GROUP

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026