Lithium Drug-Drug Interaction Study With Lurasidone HCl

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sunovion
ClinicalTrials.gov Identifier:
NCT01074073
First received: February 22, 2010
Last updated: September 6, 2011
Last verified: September 2011
  Purpose

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


Condition Intervention Phase
Schizophrenia
Drug: Lurasidone HCl
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Sunovion:

Enrollment: 24
Study Start Date: August 2008
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Lithium/Lurasidone
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.


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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01074073

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

No publications provided

Responsible Party: Sunovion
ClinicalTrials.gov Identifier: NCT01074073     History of Changes
Other Study ID Numbers: D1050247
Study First Received: February 22, 2010
Last Updated: September 6, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Sunovion:
Lithium DDI with Lurasidone HCl
Male/Female, Schizophrenia Patients

Additional relevant MeSH terms:
Psychotic Disorders
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Lithium
Lithium Carbonate
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Antimanic Agents
Antidepressive Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 22, 2014