A Clinical Pharmacology Study of K-877 Controlled Release Tablet

Inclusion criteria

• Patients with dyslipidemia had to be age 20 years or older at written informed consent(ICF)
• Men and postmenopausal women.
• Patients who have received dietary or exercise guidance from 12 weeks prior to Screening.
• Patients who have clinical laboratory records with fasting serum TG ≥ 150 mg / dL (or ≥ 200 mg / dL if not fasting) within 6 months before written informed consent.
• Patients with a fasting serum TG ≥ 150 mg / dL at Screening.

Exclusion criteria

• Patients with a fasting serum TG ≥ 500 mg / dL at Screening
• Patients who require administration of prohibited drugs during the clinical trial period after written informed consent
• 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)
• Patients with uncontrolled thyroid disease
• Patients with uncontrolled diabetes as defined by a HbA1c(NGSP) ≥ 8.0％ at Screening
• Persons with uncontrolled hypertension (SBP ≥ 160 mmHg or DBP ≥ 100 mmHg)
• Patients with an AST or ALT three times the upper limit at Screening
• Patients with cirrhosis or those with biliary obstruction
• Patients with malignant tumor or those who are judged to have a high risk of recurrence
• 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
• Patients with a history of serious drug allergies (anaphylactic shock, etc.)
• Patients with a history of hypersensitivity to pemafibrate, patients who have stopped taking pemafibrate for reasons of insufficient efficacy or safety
• 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
• Patients who have been determined inappropriate by the investigator or subinvestigator