Study of TAS3681 in Metastatic Castration Resistant Prostate Cancer

Exclusion Criteria

• •1. QTcF ≥ 450 ms, history of QTc prolongation or predisposition for QTc prolongation or family history of sudden cardiac death or QT prolongation
• •2. History or presence of heart failure or left ventricular dysfunction with ejection fraction \<40% within the previous 6 months; if \>6 months cardiac function within normal limits and free of cardiac-related symptoms
• •3. History or presence of atrial fibrillation, atrial flutter, or paroxysmal supraventricular tachycardia; the presence or history of ventricular arrhythmias including ventricular fibrillation and ventricular tachycardia
• •4. Presence of cardiac pacemaker or implantable cardioverter-defibrillator
• •5. History or presence of bradycardia or conduction abnormalities
• •6. History or presence of cardiac arrest or unexplained syncope
• •7. Hypokalemia
• •8. History of myocardial infarction or severe unstable angina
• •9. Any medication administered within 2 weeks prior to 1st dose of TAS3681 that is known to prolong the QT interval or be arrhythmogenic
• •10. Received G-CSF, radiotherapy for extended field, anticancer chemotherapy, investigational agents, or major surgery within 4 weeks of study drug administration; receipt of anticoagulant or CYP3A inhibitor within 2 weeks of study drug administration
• •11. Serious illness or medical condition that could affect the safety or tolerability of study treatments
• •12. Received prior treatment with TAS3681
• •13. User of herbal products
• •14. Any condition or reason that in the opinion of the investigator, interferes with the ability of the participant to participate in the trial
• •15. To be eligible to participate in the food effect assessment (Escalation Phase only), participants must not have a history or presence of any clinically significant abnormality involving the gastrointestinal tract and an inability to fast for a minimum of 8 hours