Midazolam Drug-Drug Interaction Study With Lurasidone HCl

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sunovion
ClinicalTrials.gov Identifier:
NCT01082263
First received: March 5, 2010
Last updated: September 6, 2011
Last verified: September 2011

March 5, 2010
September 6, 2011
October 2008
November 2008   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT01082263 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Midazolam Drug-Drug Interaction Study With Lurasidone HCl
Not Provided

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Schizophrenia Patients
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)
Midazolam/Lurasidone
Schizophrenia patient
Intervention: Drug: Lurasidone HCl
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
November 2008
November 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01082263
D1050269
Yes
Sunovion
Sunovion
Not Provided
Principal Investigator: Marina Bussel, MD CCT/Parexel
Sunovion
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP