Lithium Drug-Drug Interaction Study With Lurasidone HCl

Schizophrenia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01074073
• Other study ID #: D1050247
• Status: Completed
• Phase: Phase 1
• First received: February 22, 2010
• Last updated: September 6, 2011
• Start date: August 2008
• Est. completion date: October 2008

Study information

• Verified date: September 2011
• Source: Sunovion
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• 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.

Locations

Country	Name	City	State
United States	CCT/Parexel	Culver City	California

Sponsors (1)

Lead Sponsor	Collaborator
Sunovion

Country where clinical trial is conducted

United States,