Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the drug-drug interaction effect between Lithium and Lurasidone HCl.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lithium/Lurasidone | Other | Schizophrenia Patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
Inclusion Criteria:
Diagnosis of schizophrenia, schizoaffective disorder, or schizophreniform.
Females who participate in this study:
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.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Marina Bussel, MD | CCT/Parexel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CCT/Parexel | Culver City | California | 90232 | United States |
Not provided
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069056 | Lurasidone Hydrochloride |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |