Midazolam Drug-Drug Interaction Study With Lurasidone HCl

Schizophrenia Patients Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01082263
• Other study ID #: D1050269
• Status: Completed
• Phase: Phase 1
• First received: March 5, 2010
• Last updated: September 6, 2011
• Start date: October 2008
• Est. completion date: November 2008

Study information

• Verified date: September 2011
• Source: Sunovion
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Schizophrenia Patients

Intervention

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)

Locations

Country	Name	City	State
United States	CCT/Parexel	Culver City	California

Sponsors (1)

Lead Sponsor	Collaborator
Sunovion

Country where clinical trial is conducted

United States,