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Lithium Drug-Drug Interaction Study With Lurasidone HCl

Information source: Sunovion
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Schizophrenia

Intervention: Lurasidone HCl (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Sunovion

Official(s) and/or principal investigator(s):
Marina Bussel, MD, Principal Investigator, Affiliation: CCT/Parexel

Summary

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

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

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

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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.

Locations and Contacts

CCT/Parexel, Culver City, California 90232, United States
Additional Information

Starting date: August 2008
Last updated: September 6, 2011

Page last updated: August 23, 2015

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