Midazolam Drug-Drug Interaction Study With Lurasidone HCl

lurasidone 120 mg, midazolam 5 mg

To compare the single-dose pharmacokinetic profile of midazolam 5 mg when administered alone vs. when administered with a single-dose of lurasidone 120 mg.

To compare the single dose pharmacokinetic profile of midazolam 5 mg when administered alone vs. when administered after steady state dosing with lurasidone 120 mg.

Inclusion criteria

• 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.

Exclusion criteria

• 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.