Digoxin Drug-Drug Interaction With Lurasidone HCl
Phase 1
Completed
- Conditions
- Schizophrenia
- Registration Number
- NCT01082289
- Lead Sponsor
- Sumitomo Pharma America, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What is the mechanism of lurasidone-digoxin interaction in CYP450 metabolism pathways?
How does lurasidone compare to other antipsychotics in managing schizophrenia drug interactions?
Are there specific biomarkers that predict digoxin-lurasidone pharmacokinetic interactions in patients with schizophrenia?
What are the potential adverse events of combining lurasidone with digoxin in schizoaffective disorder treatment?
What other antipsychotic-drug interactions have been studied by Sumitomo Pharma America in phase 1 trials for schizophrenia?
Trial Locations
- Locations (1)
California Clinical Trials
🇺🇸Culver City, California, United States
California Clinical Trials🇺🇸Culver City, California, United States