A Clinical Pharmacology Study of K-877 Controlled Release Tablet

Exclusion Criteria

• •1. Patients with a fasting serum TG ≥ 500 mg / dL at Screening
• •2. Patients who require administration of prohibited drugs during the clinical trial period after written informed consent
• •3. Patients who have malabsorption or those who have had the history, or who have undergone other surgical procedures that may affect absorption (excluding appendectomy or hernia treatment etc)
• •4. Patients with uncontrolled thyroid disease
• •5. Patients with uncontrolled diabetes as defined by a HbA1c(NGSP) ≥ 8.0％ at Screening
• •6. Persons with uncontrolled hypertension (SBP ≥ 160 mmHg or DBP ≥ 100 mmHg)
• •7. Patients with an AST or ALT three times the upper limit at Screening
• •8. Patients with cirrhosis or those with biliary obstruction
• •9. Patients with malignant tumor or those who are judged to have a high risk of recurrence
• •10. Patients who have collected 400 mL or more of whole blood within 16 weeks, or 200 mL or more of whole blood within 4 weeks, or blood samples (plasma and platelet components) within 2 weeks before Screening
• •11. Patients with a history of serious drug allergies (anaphylactic shock, etc.)
• •12. Patients with a history of hypersensitivity to pemafibrate, patients who have stopped taking pemafibrate for reasons of insufficient efficacy or safety
• •13. Patients who participate in other clinical trials at the time of written informed consent or who have received clinical trials other than placebo for less than 16 weeks
• •14. Patients who have been determined inappropriate by the investigator or subinvestigator