Lithium Drug-Drug Interaction Study With Lurasidone HCl

Completed · Phase 1

Conditions studied: Schizophrenia

In brief

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

Key facts

Study ID

NCT01074073

Run by

Sumitomo Pharma America, Inc.

People needed

24

Starts

2008-08-01

Expected to finish

2008-10-01

Last updated by the study team

2011-09-08

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• CCT/Parexel — Culver City, California, United States

Full record on ClinicalTrials.gov

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