Lithium Drug-Drug Interaction Study With Lurasidone HCl

• Sponsor: Sunovion (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01074073
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arm: 1
• Duration (Months): 2
• Patients Per Site Per Month: 12

Study Details

Study Description

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.

Study Design

• Study Type: Interventional
• 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: Aug 1, 2008
• Actual Primary Completion Date: Oct 1, 2008
• Actual Study Completion Date: Oct 1, 2008

Arms and Interventions

Arm

Intervention/Treatment

Other: 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.

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• 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;

1. 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.

2. 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

Locations

	Site	City	State	Country	Postal Code
1	CCT/Parexel	Culver City	California	United States	90232

Sponsors and Collaborators

• Sunovion

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sunovion
• ClinicalTrials.gov Identifier: NCT01074073
• Other Study ID Numbers: D1050247
• First Posted: Feb 24, 2010
• Last Update Posted: Sep 8, 2011
• Last Verified: Sep 1, 2011

• Keywords provided by Sunovion: Lithium DDI with Lurasidone HCl; Male/Female, Schizophrenia Patients
• Additional relevant MeSH terms: Schizophrenia; Lurasidone Hydrochloride

Study Results

No Results Posted as of Sep 8, 2011