Lithium Drug-Drug Interaction Study With Lurasidone HCl

NCT ID: NCT01074073

Last Updated: 2011-09-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2008-10-31

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.

Conditions

Schizophrenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

Lithium/Lurasidone

Schizophrenia Patients

Group Type: OTHER

Lurasidone HCl

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sumitomo Pharma America, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marina Bussel, MD

Role: PRINCIPAL_INVESTIGATOR

CCT/Parexel

Locations

CCT/Parexel

Culver City, California, United States

Countries

United States

Other Identifiers

D1050247

Identifier Type: -

Identifier Source: org_study_id