Midazolam Drug-Drug Interaction Study With Lurasidone HCl

NCT01082263 | Completed Phase 1 DMC

• 1 other identifier: D1050269
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Schizophrenia Patients

Keywords

DDI study between Midazolam and Lurasidone HCl; Male and Female

Study Arms (1)

Midazolam/Lurasidone

OTHER

Schizophrenia patient

Drug: Lurasidone HCl

Interventions

Lurasidone HCl DRUG

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)

Midazolam/Lurasidone

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Sumitomo Pharma America, Inc.: lead

Study Sites (1)

CCT/Parexel

Culver City, California, 90232, United States

Location

MeSH Terms

Interventions

Lurasidone Hydrochloride

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Marina Bussel, MD

  CCT/Parexel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2010
• First Posted: March 8, 2010
• Study Start: October 1, 2008
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: September 8, 2011

Record last verified: 2011-09

Locations

US (1)