Clinical trial NCT04079530: A Clinical Pharmacology Study of K-877 Controlled Release Tablet
Official title: A Multicenter, Randomized, Active-controlled, Single-blind, 2-Period, 12-Sequence Crossover Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Pemafibrate in Patients With Dyslipidemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dyslipidemias
Lead sponsor: Kowa Company, Ltd.
Sponsor class: INDUSTRY
First posted: 2019-09-06
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Efficacy: % change from baseline in fasting serum TG(mg/dL)
timeFrame: 4 week after administration in each period
Secondary outcomes:
measure: % change from baseline in fasting HDL-C levels(mg/dL)
timeFrame: 4 week after administration in each period
measure: % change from baseline in fasting LDL-C levels(mg/dL)
timeFrame: 4 week after administration in each period
measure: % change from baseline in fasting non-HDL-C levels(mg/dL)
timeFrame: 4 week after administration in each period
measure: % change from baseline in fasting Total Cholesterol levels(mg/dL)
timeFrame: 4 week after administration in each period
Other outcomes:
Locations:
city: Osaka
country: Japan
facility: Medical Corporation Heishinkai OPHAC Hospital
Study officials:
References: