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A Clinical Pharmacology Study of K-877 Controlled Release Tablet

Phase 2
Completed
Conditions
Dyslipidemias
Interventions
Drug: K-877 IR 0.2 mg/day
Drug: K-877 CR 0.4 mg/day
Drug: K-877 CR 0.8 mg/day
Registration Number
NCT04079530
Lead Sponsor
Kowa Company, Ltd.
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
60
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
Treatment JK-877 IR 0.2 mg/dayPeriod1:K-877 CR 0.8 mg/day, Period2:K-877 IR 0.2 mg/day (postprandial)
Treatment GK-877 CR 0.8 mg/dayPeriod1:K-877 CR 0.4 mg/day, Period2:K-877 CR 0.8 mg/day (pre-meal)
Treatment HK-877 CR 0.4 mg/dayPeriod1:K-877 CR 0.4 mg/day, Period2:K-877 CR 0.8 mg/day (postprandial)
Treatment KK-877 CR 0.4 mg/dayPeriod1:K-877 CR 0.8 mg/day, Period2:K-877 CR 0.4 mg/day (pre-meal)
Treatment FK-877 IR 0.2 mg/dayPeriod1:K-877 CR 0.4 mg/day, Period2:K-877 IR 0.2 mg/day (postprandial)
Treatment GK-877 CR 0.4 mg/dayPeriod1:K-877 CR 0.4 mg/day, Period2:K-877 CR 0.8 mg/day (pre-meal)
Treatment JK-877 CR 0.8 mg/dayPeriod1:K-877 CR 0.8 mg/day, Period2:K-877 IR 0.2 mg/day (postprandial)
Treatment AK-877 IR 0.2 mg/dayPeriod1:K-877 IR 0.2 mg/day, Period2:K-877 CR 0.4 mg/day (pre-meal)
Treatment CK-877 IR 0.2 mg/dayPeriod1:K-877 IR 0.2 mg/day, Period2:K-877 CR 0.8 mg/day (pre-meal)
Treatment AK-877 CR 0.4 mg/dayPeriod1:K-877 IR 0.2 mg/day, Period2:K-877 CR 0.4 mg/day (pre-meal)
Treatment DK-877 IR 0.2 mg/dayPeriod1:K-877 IR 0.2 mg/day, Period2:K-877 CR 0.8 mg/day (postprandial)
Treatment FK-877 CR 0.4 mg/dayPeriod1:K-877 CR 0.4 mg/day, Period2:K-877 IR 0.2 mg/day (postprandial)
Treatment BK-877 IR 0.2 mg/dayPeriod1:K-877 IR 0.2 mg/day, Period2:K-877 CR 0.4 mg/day (postprandial)
Treatment BK-877 CR 0.4 mg/dayPeriod1:K-877 IR 0.2 mg/day, Period2:K-877 CR 0.4 mg/day (postprandial)
Treatment CK-877 CR 0.8 mg/dayPeriod1:K-877 IR 0.2 mg/day, Period2:K-877 CR 0.8 mg/day (pre-meal)
Treatment DK-877 CR 0.8 mg/dayPeriod1:K-877 IR 0.2 mg/day, Period2:K-877 CR 0.8 mg/day (postprandial)
Treatment EK-877 IR 0.2 mg/dayPeriod1:K-877 CR 0.4 mg/day, Period2:K-877 IR 0.2 mg/day (pre-meal)
Treatment EK-877 CR 0.4 mg/dayPeriod1:K-877 CR 0.4 mg/day, Period2:K-877 IR 0.2 mg/day (pre-meal)
Treatment HK-877 CR 0.8 mg/dayPeriod1:K-877 CR 0.4 mg/day, Period2:K-877 CR 0.8 mg/day (postprandial)
Treatment IK-877 IR 0.2 mg/dayPeriod1:K-877 CR 0.8 mg/day, Period2:K-877 IR 0.2 mg/day (pre-meal)
Treatment IK-877 CR 0.8 mg/dayPeriod1:K-877 CR 0.8 mg/day, Period2:K-877 IR 0.2 mg/day (pre-meal)
Treatment KK-877 CR 0.8 mg/dayPeriod1:K-877 CR 0.8 mg/day, Period2:K-877 CR 0.4 mg/day (pre-meal)
Treatment LK-877 CR 0.8 mg/dayPeriod1:K-877 CR 0.8 mg/day, Period2:K-877 CR 0.4 mg/day (postprandial)
Treatment LK-877 CR 0.4 mg/dayPeriod1:K-877 CR 0.8 mg/day, Period2:K-877 CR 0.4 mg/day (postprandial)
Primary Outcome Measures
NameTimeMethod
Efficacy: % change from baseline in fasting serum TG(mg/dL)4 week after administration in each period
Secondary Outcome Measures
NameTimeMethod
% change from baseline in fasting non-HDL-C levels(mg/dL)4 week after administration in each period
% 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 Total Cholesterol levels(mg/dL)4 week after administration in each period

Trial Locations

Locations (1)

Medical Corporation Heishinkai OPHAC Hospital

🇯🇵

Osaka, Japan

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