Midazolam Drug-Drug Interaction Study With Lurasidone HCl

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

Intervention(s) in this Clinical Trial

• Drug: Lurasidone HCl
  • Day1: 5 mg midazolam (2.5 mL of the 2 mg/mL syrup) Day6: 120 mg lurasidone (three 40 mg tablets) + 5 mg midazolam (2.5 mL of the 2 mg/mL syrup) Day 7-12: 120 mg lurasidone (three 40 mg tablets) 120 mg lurasidone (three 40 mg tablets) on Day 13 + 5 mg midazolam (2.5 mL of the 2 mg/mL syrup)

Arms, Groups and Cohorts in this Clinical Trial

• Other: Midazolam/Lurasidone
  • Schizophrenia patient

Inclusion Criteria:

• 1. Diagnosis of schizophrenia, schizoaffective disorder, or schizophreniform disorders
• 2. 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.
• 3. Males must be willing to remain sexually abstinent or use an effective method of birth control from Day -5 to 90 days after discharge.
• 4. Able and agree to remain off of prior antipsychotic medication for the duration of the study.

Exclusion Criteria:

• 1. Known presence or history of renal or hepatic insufficiency.
• 2. A history or presence of abnormal electrocardiogram (ECG5. Known history or presence of clinically significant intolerance to antipsychotic medications.
• 3. 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).
• 4. 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.
• 5. Participated in another clinical trial or receiving an investigational product within 30 days prior to drug administration.
• 6. 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.
• 7. Received depot neuroleptics unless the last injection was at least 1 treatment cycle before Day -5.
• 8. Difficulty fasting or consuming the FDA high fat meals.
• 9. At risk with midazolam dosing with respiratory disease or impaired gag reflex, in the opinion of the investigator.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Sunovion Industry

Overall Clinical Trial Officials and Contacts

Marina Bussel, MD Principal Investigator CCT/Parexel  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01082263

Study ID Number: D1050269

ClinicalTrials.gov Identifier: NCT01082263

Health Authority: United States: Food and Drug Administration