Lithium Drug-Drug Interaction Study With Lurasidone HCl
This study has been completed.
Information provided by (Responsible Party):
First received: February 22, 2010
Last updated: September 6, 2011
Last verified: September 2011
The purpose of this study is to evaluate the drug-drug interaction effect between Lithium and Lurasidone HCl.
Drug: Lurasidone HCl
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
||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:
| Study Completion Date:
| Primary Completion Date:
||October 2008 (Final data collection date for primary outcome measure)
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.
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.
|Ages Eligible for Study:
||18 Years to 65 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Diagnosis of schizophrenia, schizoaffective disorder, or schizophreniform.
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;
- 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.
- Able and agree to remain off of prior antipsychotic medication for the duration of the study.
- 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.
- Positive test results within 30 days prior to the start of the study for:
- Participated in another clinical trial or receiving an investigational product within 30 days prior to drug administration.
- Use of concomitant medications that prolong the QT/QTc interval within 14 days prior to Day - 5 to follow-up
- Use of a monoamine oxidase inhibitor within 21 days prior to Day 1 to Restabilization.
- Received depot neuroleptics unless the last injection was at least 1 treatment cycle before Day -5.
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
|Culver City, California, United States, 90232 |
||Marina Bussel, MD
History of Changes
|Other Study ID Numbers:
|Study First Received:
||February 22, 2010
||September 6, 2011
||United States: Food and Drug Administration
Keywords provided by Sunovion:
Lithium DDI with Lurasidone HCl
Male/Female, Schizophrenia Patients
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 02, 2016
Schizophrenia and Disorders with Psychotic Features
Central Nervous System Agents
Central Nervous System Depressants
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs