A Clinical Pharmacology Study of K-877 Controlled Release Tablet

Study Overview
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Brief Summary
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A study to compare the efficacy, safety, and pharmacokinetics of K-877 controlled release tablets with a current normal K-877 tablet in dyslipidemia.

Official Title
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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

Conditions
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Dyslipidemias

Intervention / Treatment
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* Drug: K-877 IR 0.2 mg/day
* Drug: K-877 CR 0.4 mg/day
* Drug: K-877 CR 0.8 mg/day


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment A<br>Period1:K-877 IR 0.2 mg/day, Period2:K-877 CR 0.4 mg/day (pre-meal) | Drug: K-877 IR 0.2 mg/day<br>* K-877 IR 0.1 mg tablet<br>* Other names: Pemafibrate;Drug: K-877 CR 0.4 mg/day<br>* K-877 CR 0.4 mg tablet<br>* Other names: Pemafibrate;|
| Experimental: Treatment B<br>Period1:K-877 IR 0.2 mg/day, Period2:K-877 CR 0.4 mg/day (postprandial) | Drug: K-877 IR 0.2 mg/day<br>* K-877 IR 0.1 mg tablet<br>* Other names: Pemafibrate;Drug: K-877 CR 0.4 mg/day<br>* K-877 CR 0.4 mg tablet<br>* Other names: Pemafibrate;|
| Experimental: Treatment C<br>Period1:K-877 IR 0.2 mg/day, Period2:K-877 CR 0.8 mg/day (pre-meal) | Drug: K-877 IR 0.2 mg/day<br>* K-877 IR 0.1 mg tablet<br>* Other names: Pemafibrate;Drug: K-877 CR 0.8 mg/day<br>* Two K-877 CR 0.4 mg tablet<br>* Other names: Pemafibrate;|
| Experimental: Treatment D<br>Period1:K-877 IR 0.2 mg/day, Period2:K-877 CR 0.8 mg/day (postprandial) | Drug: K-877 IR 0.2 mg/day<br>* K-877 IR 0.1 mg tablet<br>* Other names: Pemafibrate;Drug: K-877 CR 0.8 mg/day<br>* Two K-877 CR 0.4 mg tablet<br>* Other names: Pemafibrate;|
| Experimental: Treatment E<br>Period1:K-877 CR 0.4 mg/day, Period2:K-877 IR 0.2 mg/day (pre-meal) | Drug: K-877 IR 0.2 mg/day<br>* K-877 IR 0.1 mg tablet<br>* Other names: Pemafibrate;Drug: K-877 CR 0.4 mg/day<br>* K-877 CR 0.4 mg tablet<br>* Other names: Pemafibrate;|
| Experimental: Treatment F<br>Period1:K-877 CR 0.4 mg/day, Period2:K-877 IR 0.2 mg/day (postprandial) | Drug: K-877 IR 0.2 mg/day<br>* K-877 IR 0.1 mg tablet<br>* Other names: Pemafibrate;Drug: K-877 CR 0.4 mg/day<br>* K-877 CR 0.4 mg tablet<br>* Other names: Pemafibrate;|
| Experimental: Treatment G<br>Period1:K-877 CR 0.4 mg/day, Period2:K-877 CR 0.8 mg/day (pre-meal) | Drug: K-877 CR 0.4 mg/day<br>* K-877 CR 0.4 mg tablet<br>* Other names: Pemafibrate;Drug: K-877 CR 0.8 mg/day<br>* Two K-877 CR 0.4 mg tablet<br>* Other names: Pemafibrate;|
| Experimental: Treatment H<br>Period1:K-877 CR 0.4 mg/day, Period2:K-877 CR 0.8 mg/day (postprandial) | Drug: K-877 CR 0.4 mg/day<br>* K-877 CR 0.4 mg tablet<br>* Other names: Pemafibrate;Drug: K-877 CR 0.8 mg/day<br>* Two K-877 CR 0.4 mg tablet<br>* Other names: Pemafibrate;|
| Experimental: Treatment I<br>Period1:K-877 CR 0.8 mg/day, Period2:K-877 IR 0.2 mg/day (pre-meal) | Drug: K-877 IR 0.2 mg/day<br>* K-877 IR 0.1 mg tablet<br>* Other names: Pemafibrate;Drug: K-877 CR 0.8 mg/day<br>* Two K-877 CR 0.4 mg tablet<br>* Other names: Pemafibrate;|
| Experimental: Treatment J<br>Period1:K-877 CR 0.8 mg/day, Period2:K-877 IR 0.2 mg/day (postprandial) | Drug: K-877 IR 0.2 mg/day<br>* K-877 IR 0.1 mg tablet<br>* Other names: Pemafibrate;Drug: K-877 CR 0.8 mg/day<br>* Two K-877 CR 0.4 mg tablet<br>* Other names: Pemafibrate;|
| Experimental: Treatment K<br>Period1:K-877 CR 0.8 mg/day, Period2:K-877 CR 0.4 mg/day (pre-meal) | Drug: K-877 CR 0.4 mg/day<br>* K-877 CR 0.4 mg tablet<br>* Other names: Pemafibrate;Drug: K-877 CR 0.8 mg/day<br>* Two K-877 CR 0.4 mg tablet<br>* Other names: Pemafibrate;|
| Experimental: Treatment L<br>Period1:K-877 CR 0.8 mg/day, Period2:K-877 CR 0.4 mg/day (postprandial) | Drug: K-877 CR 0.4 mg/day<br>* K-877 CR 0.4 mg tablet<br>* Other names: Pemafibrate;Drug: K-877 CR 0.8 mg/day<br>* Two K-877 CR 0.4 mg tablet<br>* Other names: Pemafibrate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy: % change from baseline in fasting serum TG(mg/dL) |  | 4 week after administration in each period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |