Lithium Drug-Drug Interaction Study With Lurasidone HCl

Phase 1

Completed

• Conditions: Schizophrenia
• Interventions: Drug: Lurasidone HCl

• Registration Number: NCT01074073
• Lead Sponsor: Sumitomo Pharma America, Inc.

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 Timeline

• Study Start: 2008-08
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Study First Submitted: 2010-02-22
• Study First Submitted QC: 2010-02-22
• Study First Posted: 2010-02-24
• Status Verified: 2011-09
• Last Update Submitted: 2011-09-06
• Last Update Posted: 2011-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lithium/Lurasidone	Lurasidone HCl	Schizophrenia Patients

Trial Locations

Locations (1)

CCT/Parexel; 🇺🇸 Culver City, California, United States