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.
1 other identifier
interventional
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 schizophrenia
Started Sep 2008
Shorter than P25 for phase_1 schizophrenia
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
March 5, 2010
CompletedFirst Posted
Study publicly available on registry
March 8, 2010
CompletedSeptember 8, 2011
September 1, 2011
1 month
March 5, 2010
September 6, 2011
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Male and female 18 to 65 years of age
- BMI \>= 19.5 and \<= 37 kg/m2
- No clinically relevant abnormal laboratory values
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
California Clinical Trials
Culver City, California, 90232, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marina Bussel, MD
California Clinical Trials
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 5, 2010
First Posted
March 8, 2010
Study Start
September 1, 2008
Primary Completion
October 1, 2008
Study Completion
October 1, 2008
Last Updated
September 8, 2011
Record last verified: 2011-09