Dyslipidemias
Conditions
Brief summary
A study to compare the efficacy, safety, and pharmacokinetics of K-877 controlled release tablets with a current normal K-877 tablet in dyslipidemia.
Interventions
DRUGK-877 IR 0.2 mg/day
K-877 IR 0.1 mg tablet
DRUGK-877 CR 0.4 mg/day
K-877 CR 0.4 mg tablet
DRUGK-877 CR 0.8 mg/day
Two K-877 CR 0.4 mg tablet
Sponsors
Kowa Company, Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients with dyslipidemia had to be age 20 years or older at written informed consent(ICF) 2. Men and postmenopausal women. 3. Patients who have received dietary or exercise guidance from 12 weeks prior to Screening. 4. 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. 5. Patients with a fasting serum TG ≥ 150 mg / dL at Screening.
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy: % change from baseline in fasting serum TG(mg/dL) | 4 week after administration in each period |
Secondary
| Measure | Time frame |
|---|---|
| % change from baseline in fasting HDL-C levels(mg/dL) | 4 week after administration in each period |
| % change from baseline in fasting LDL-C levels(mg/dL) | 4 week after administration in each period |
| % change from baseline in fasting non-HDL-C levels(mg/dL) | 4 week after administration in each period |
| % change from baseline in fasting Total Cholesterol levels(mg/dL) | 4 week after administration in each period |
Countries
Japan
Outcome results
None listed