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Midazolam Drug-Drug Interaction Study With Lurasidone HCl

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01082263
Recruitment Status : Completed
First Posted : March 8, 2010
Last Update Posted : September 8, 2011
Information provided by (Responsible Party):

Study Description
Brief Summary:
A Phase I, Drug-Drug Interaction Study between Midazolam and Lurasidone HCl.

Condition or disease Intervention/treatment Phase
Schizophrenia Patients Drug: Lurasidone HCl Phase 1

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Study Start Date : October 2008
Primary Completion Date : November 2008
Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Schizophrenia patient
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)

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01082263

United States, California
Culver City, California, United States, 90232
Sponsors and Collaborators
Principal Investigator: Marina Bussel, MD CCT/Parexel
More Information

Responsible Party: Sunovion
ClinicalTrials.gov Identifier: NCT01082263     History of Changes
Other Study ID Numbers: D1050269
First Posted: March 8, 2010    Key Record Dates
Last Update Posted: September 8, 2011
Last Verified: September 2011

Keywords provided by Sunovion:
DDI study between Midazolam and Lurasidone HCl
Male and Female

Additional relevant MeSH terms:
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Lurasidone Hydrochloride
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipsychotic Agents
Adrenergic alpha-2 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Serotonin Agents
Dopamine D2 Receptor Antagonists
Dopamine Antagonists
Dopamine Agents