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

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.

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;