Lithium Drug-Drug Interaction Study With Lurasidone HCl

Sumitomo Pharma

Status and phase: Completed; Phase 1

Conditions: Schizophrenia

Treatments: Drug: Lurasidone HCl

Study type: Interventional

Funder types: Industry

Identifiers

NCT01074073

D1050247

Details and patient eligibility

About

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

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

24 participants in 1 patient group

Lithium/Lurasidone

Other group

Description:

Schizophrenia Patients

Treatment:

Drug: Lurasidone HCl