Midazolam Drug-Drug Interaction Study With Lurasidone HCl

Phase 1

Completed

• Conditions: Schizophrenia Patients
• Interventions: Drug: Lurasidone HCl

• Registration Number: NCT01082263
• Lead Sponsor: Sumitomo Pharma America, Inc.

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2008-10
• Primary Completion: 2008-11
• Study Completion: 2008-11
• Study First Submitted: 2010-03-05
• Study First Submitted QC: 2010-03-05
• Study First Posted: 2010-03-08
• Status Verified: 2011-09
• Last Update Submitted: 2011-09-06
• Last Update Posted: 2011-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Midazolam/Lurasidone	Lurasidone HCl	Schizophrenia patient

Trial Locations

Locations (1)

CCT/Parexel; 🇺🇸 Culver City, California, United States