Midazolam Drug-Drug Interaction Study With Lurasidone HCl

Completed · Phase 1

Conditions studied: Schizophrenia Patients

In brief

A Phase I, Drug-Drug Interaction Study between Midazolam and Lurasidone HCl.

Key facts

Study ID

NCT01082263

Run by

Sumitomo Pharma America, Inc.

People needed

24

Starts

2008-10-01

Expected to finish

2008-11-01

Last updated by the study team

2011-09-08

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of schizophrenia, schizoaffective disorder, or schizophreniform disorders
• Females who participate in this study:
• are unable to have children -OR- are willing to remain abstinent from Day -5 to 90 days after discharge; -OR- are willing to use an effective method of double-barrier birth control from Day -5 to 90 days after discharge.
• Males must be willing to remain sexually abstinent or use an effective method of birth control from Day -5 to 90 days after discharge.
• Able and agree to remain off of prior antipsychotic medication for the duration of the study.

You may not qualify if…

• Known presence or history of renal or hepatic insufficiency.
• A history or presence of abnormal electrocardiogram (ECG5. Known history or presence of clinically significant intolerance to antipsychotic medications.
• Significant orthostatic hypotension (i.e. a drop in systolic blood pressure of 30 mmHg or more and/or drop in diastolic blood pressure of 20 mmHg or more on standing).
• Presence or history (within the last year) of a medical or surgical condition (e.g. gastrointestinal disease) that might interfere with the absorption, metabolism, or excretion of orally administered lurasidone.
• Participated in another clinical trial or receiving an investigational product within 30 days prior to drug administration.
• Use of concomitant medications that prolong the QT/QTc interval within 14 days prior to Day -5 to follow-up including but not limited to those listed in Appendix 19.5.
• Received depot neuroleptics unless the last injection was at least 1 treatment cycle before Day -5.
• Difficulty fasting or consuming the FDA high fat meals.
• At risk with midazolam dosing with respiratory disease or impaired gag reflex, in the opinion of the investigator.

Where it is running

• CCT/Parexel — Culver City, California, United States

Full record on ClinicalTrials.gov

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