Effect of Calories and Fat Content on the Pharmacokinetics of Lurasidone HCl
A Phase 1, Open-Label Study to Determine the Effect of Calories and Fat Content on the Pharmacokinetics of Repeated Dose Lurasidone 120 mg in Subjects With Schizophrenia, Schizoaffective Disorder, or Schizophreniform Disorder.
1 other identifier
interventional
26
1 country
2
Brief Summary
The objective of this study is to evaluate the effect of calorie and fat content on the pharmacokinetics of Lurasidone HCl in subjects with schizophrenia, schizoaffective disorder, or schizophreniform disorder.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started May 2009
Shorter than P25 for phase_1
2 active sites
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
May 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2009
CompletedFirst Submitted
Initial submission to the registry
February 23, 2010
CompletedFirst Posted
Study publicly available on registry
February 24, 2010
CompletedSeptember 8, 2011
September 1, 2011
4 months
February 23, 2010
September 6, 2011
Conditions
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 14 days prior to study drug administration
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
California Clinical Trials
Glendale, California, 91206, United States
Clinical Research Institute
Wichita, Kansas, 67207, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 23, 2010
First Posted
February 24, 2010
Study Start
May 1, 2009
Primary Completion
September 1, 2009
Study Completion
September 1, 2009
Last Updated
September 8, 2011
Record last verified: 2011-09