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

Completed · Phase 1

Conditions studied: Pharmacokinetics, Metabolism

In brief

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

Key facts

Study ID

NCT01082146

Run by

Sumitomo Pharma America, Inc.

People needed

6

Starts

2008-08-01

Expected to finish

2008-08-01

Last updated by the study team

2014-04-03

Who can join

Age: 18 and older, up to 45. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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;

Where it is running

• Covance Global Clinical Research Unit Inc. — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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