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

• Status: Completed
• Trial end date: 2008-08-01
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Sunovion
• Treatments: Lurasidone Hydrochloride

Criteria

Inclusion Criteria:

1. within a BMI range of 18.0 to 28.0 kg/m2 inclusive;

2. males will either be sterile or agree to use from Check-in until 45 days following Study Completion/Discharge approved methods of contraception

3. able to comprehend and willing to sign an Informed Consent Form (ICF);

4. able to void urine on a daily basis and 1 to 2 bowel movements per day.

5. able to swallow 60 mL of dosing suspension.

Exclusion Criteria:

1. history or presence of an abnormal ECG

2. participation in more than 1 other radiolabeled investigational study drug trial within 12 months prior to Check-in.

3. exposure to significant radiation within 12 months prior to Check-in;

4. participation in any other investigational study drug trial

5. use of any prescription medications/products within 14 days prior to Check-in

6. 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;

7. receipt of blood products within 2 months prior to Check-in;