Lithium Drug-Drug Interaction Study With Lurasidone HCl

NCT01074073 | Completed Phase 1 DMC

• 1 other identifier: D1050247
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Schizophrenia

Keywords

Lithium DDI with Lurasidone HCl; Male/Female, Schizophrenia Patients

Study Arms (1)

Lithium/Lurasidone

OTHER

Schizophrenia Patients

Drug: Lurasidone HCl

Interventions

Lurasidone HCl 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.

Lithium/Lurasidone

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of schizophrenia, schizoaffective disorder, or schizophreniform.
• 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;
• 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.
• Able and agree to remain off of prior antipsychotic medication for the duration of the study.

You may not qualify if:

• 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.
• Positive test results within 30 days prior to the start of the study for:
• Participated in another clinical trial or receiving an investigational product within 30 days prior to drug administration.
• Use of concomitant medications that prolong the QT/QTc interval within 14 days prior to Day - 5 to follow-up
• Use of a monoamine oxidase inhibitor within 21 days prior to Day 1 to Restabilization.
• Received depot neuroleptics unless the last injection was at least 1 treatment cycle before Day -5.

Sponsors & Collaborators

• Sumitomo Pharma America, Inc.: lead

Study Sites (1)

CCT/Parexel

Culver City, California, 90232, United States

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Lurasidone Hydrochloride

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Marina Bussel, MD

  CCT/Parexel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2010
• First Posted: February 24, 2010
• Study Start: August 1, 2008
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: September 8, 2011

Record last verified: 2011-09

Locations

US (1)