Lithium Drug-Drug Interaction Study With Lurasidone HCl

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

Tracking Information

• First Submitted Date: February 22, 2010
• First Posted Date: February 24, 2010
• Last Update Posted Date: September 8, 2011
• Study Start Date: August 2008
• Actual Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures: Not Provided
• Original Primary Outcome Measures: Not Provided
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Lithium Drug-Drug Interaction Study With Lurasidone HCl
• 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
• Brief Summary: The purpose of this study is to evaluate the drug-drug interaction effect between Lithium and Lurasidone HCl.
• 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.
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label)
• Condition: Schizophrenia

Intervention

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.

Study Arms

Lithium/Lurasidone

Schizophrenia Patients

Intervention: Drug: Lurasidone HCl

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 22, 2010): 24
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: October 2008
• Actual Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01074073
• Other Study ID Numbers: D1050247
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Sunovion
• Study Sponsor: Sunovion
• Collaborators: Not Provided

Investigators

• Principal Investigator: Marina Bussel, MD; CCT/Parexel

• PRS Account: Sunovion
• Verification Date: September 2011