RI-AME Study OF [ISOTHIAZOLYL-3-14C]-LURASIDONE

Study Overview
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Brief Summary
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This will be an open-label, non-randomized, absorption, metabolism, and excretion study of Lurasidone administered in a suspension at 40 mg to 6 normal healthy male subjects in a postprandial state

Detailed Description
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A Phase 1 Study to Investigate the Absorption, Metabolism, and Excretion of [Isothiazolyl-3-14C]-Lurasidone Following Postprandial Single Oral Dose Administration in Healthy Male Subjects.

Official Title
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A Phase 1 Study to Investigate the Absorption, Metabolism, and Excretion of [Issthiazolyl-3-14C]-Lurasidone Following Postprandial Single Oral Dose Administration in Health Male Subjects

Conditions
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Pharmacokinetics, Metabolism

Intervention / Treatment
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* Drug: Lurasidone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: within a BMI range of 18.0 to 28.0 kg/m2 inclusive; males will either be sterile or agree to use from Check-in until 45 days following Study Completion/Discharge approved methods of contraception able to comprehend and willing to sign an Informed Consent Form (ICF); able to void urine on a daily basis and 1 to 2 bowel movements per day. able to swallow 60 mL of dosing suspension. Exclusion Criteria: history or presence of an abnormal ECG participation in more than 1 other radiolabeled investigational study drug trial within 12 months prior to Check-in. exposure to significant radiation within 12 months prior to Check-in; participation in any other investigational study drug trial use of any prescription medications/products within 14 days prior to Check-in use of any inhibitors or inducers of CYP3A4 taken within 30 days prior to Check-in, including but not limited to drugs listed in Appendix E; receipt of blood products within 2 months prior to Check-in;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lurasidone<br>LURASIDONE 40mg | Drug: Lurasidone<br>* 40 mg suspension, PO, for 7 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the pharmacokinetics (PK) of a postprandial single dose of 40 mg (150 Ci 5.55 Megabecquerels (MBq)) [Isothiazolyl-3-14C-Lurasidone and its metabolites |  | 28 days | 
| To determine the whole blood and serum concentrations of total radioactivity of [Isothiazolyl-3-14C]-Lurasidone (150 Ci). |  | 28 days | 
| To determine the urinary and fecal recovery of total radioactivity of [Isothiazolyl-3-14C]-Lurasidone (150 Ci). |  | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the safety of 40 mg [Isothiazolyl-3-14C]-Lurasidone |  | 28 days | 
| To characterize and identify metabolites of Lurasidone in serum and urine |  | 28 days | 
| To determine serum concentrations of Lurasidone |  | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pharmacokinetics, lurasidone