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Lithium 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. Identifier: NCT01074073
Recruitment Status : Completed
First Posted : February 24, 2010
Last Update Posted : September 8, 2011
Information provided by (Responsible Party):

Brief Summary:
The purpose of this study is to evaluate the drug-drug interaction effect between Lithium and Lurasidone HCl.

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

Detailed Description:
To compare the steady state pharmacokinetic profile of lurasidone 120 mg QD when administered alone vs. the steady state pharmacokinetic profile of lurasidone 120 mg QD when coadministered with steady state lithium 600 mg BID.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: A Phase 1, Open-Label, 2-Period, Sequential, Drug-Drug Interaction Study To Determine The Effect Of Lithium 600 Mg BID On The Safety And Pharmacokinetics Of Lurasidone 120 Mg QD In Patients With Schizophrenia Or Schizoaffective Disorder
Study Start Date : August 2008
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008

Arm Intervention/treatment
Schizophrenia Patients
Drug: Lurasidone HCl

lurasidone HCl 40 mg tablets administered orally as three tablets (120 mg) once a day (QD).

Lithium 300 mg capsules administered orally as two capsules (600 mg) twice a day (BID).

On dosing days, breakfast will be served 30 minutes prior to the planned dosing time. Patients must consume the breakfast within 30 minutes or less. Dosing will take place 30 minutes after the start of breakfast.

Information from the National Library of Medicine

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

Inclusion Criteria:

  1. Diagnosis of schizophrenia, schizoaffective disorder, or schizophreniform.
  2. Females who participate in this study:

    • are unable to have children-OR-
    • are willing to remain abstinent from Day -5 until 90 days after discharge;
  3. Males must be willing to remain sexually abstinent or use an effective method of birth control (e.g. condom) from Day -5 until 90 days after discharge.
  4. Able and agree to remain off of prior antipsychotic medication for the duration of the study.

Exclusion Criteria:

  1. 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.
  2. Positive test results within 30 days prior to the start of the study for:
  3. Participated in another clinical trial or receiving an investigational product within 30 days prior to drug administration.
  4. Use of concomitant medications that prolong the QT/QTc interval within 14 days prior to Day - 5 to follow-up
  5. Use of a monoamine oxidase inhibitor within 21 days prior to Day 1 to Restabilization.
  6. Received depot neuroleptics unless the last injection was at least 1 treatment cycle before Day -5.

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 identifier (NCT number): NCT01074073

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United States, California
Culver City, California, United States, 90232
Sponsors and Collaborators
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Principal Investigator: Marina Bussel, MD CCT/Parexel
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Responsible Party: Sunovion Identifier: NCT01074073    
Other Study ID Numbers: D1050247
First Posted: February 24, 2010    Key Record Dates
Last Update Posted: September 8, 2011
Last Verified: September 2011
Keywords provided by Sunovion:
Lithium DDI with Lurasidone HCl
Male/Female, Schizophrenia Patients
Additional relevant MeSH terms:
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Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Lurasidone Hydrochloride
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Adrenergic alpha-2 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Serotonin Agents
Dopamine D2 Receptor Antagonists
Dopamine Antagonists
Dopamine Agents