Back to resultsA Clinical Pharmacology Study of K-877 Controlled Release Tablet
Primary Purpose
Dyslipidemias
Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
K-877 IR 0.2 mg/day
K-877 CR 0.4 mg/day
K-877 CR 0.8 mg/day
Sponsored by
About this trial
This is an interventional treatment trial for Dyslipidemias
Eligibility Criteria
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
Sites / Locations
- Medical Corporation Heishinkai OPHAC Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm 10
Arm 11
Arm 12
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Treatment A
Treatment B
Treatment C
Treatment D
Treatment E
Treatment F
Treatment G
Treatment H
Treatment I
Treatment J
Treatment K
Treatment L
Arm Description
Period1:K-877 IR 0.2 mg/day, Period2:K-877 CR 0.4 mg/day (pre-meal)
Period1:K-877 IR 0.2 mg/day, Period2:K-877 CR 0.4 mg/day (postprandial)
Period1:K-877 IR 0.2 mg/day, Period2:K-877 CR 0.8 mg/day (pre-meal)
Period1:K-877 IR 0.2 mg/day, Period2:K-877 CR 0.8 mg/day (postprandial)
Period1:K-877 CR 0.4 mg/day, Period2:K-877 IR 0.2 mg/day (pre-meal)
Period1:K-877 CR 0.4 mg/day, Period2:K-877 IR 0.2 mg/day (postprandial)
Period1:K-877 CR 0.4 mg/day, Period2:K-877 CR 0.8 mg/day (pre-meal)
Period1:K-877 CR 0.4 mg/day, Period2:K-877 CR 0.8 mg/day (postprandial)
Period1:K-877 CR 0.8 mg/day, Period2:K-877 IR 0.2 mg/day (pre-meal)
Period1:K-877 CR 0.8 mg/day, Period2:K-877 IR 0.2 mg/day (postprandial)
Period1:K-877 CR 0.8 mg/day, Period2:K-877 CR 0.4 mg/day (pre-meal)
Period1:K-877 CR 0.8 mg/day, Period2:K-877 CR 0.4 mg/day (postprandial)
Outcomes
Primary Outcome Measures
Efficacy: % change from baseline in fasting serum TG(mg/dL)
Secondary Outcome Measures
% change from baseline in fasting HDL-C levels(mg/dL)
% change from baseline in fasting LDL-C levels(mg/dL)
% change from baseline in fasting non-HDL-C levels(mg/dL)
% change from baseline in fasting Total Cholesterol levels(mg/dL)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04079530
Brief Title
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
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
September 13, 2019 (Actual)
Primary Completion Date
December 24, 2019 (Actual)
Study Completion Date
March 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kowa Company, Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslipidemias
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment A
Arm Type
Experimental
Arm Description
Period1:K-877 IR 0.2 mg/day, Period2:K-877 CR 0.4 mg/day (pre-meal)
Arm Title
Treatment B
Arm Type
Experimental
Arm Description
Period1:K-877 IR 0.2 mg/day, Period2:K-877 CR 0.4 mg/day (postprandial)
Arm Title
Treatment C
Arm Type
Experimental
Arm Description
Period1:K-877 IR 0.2 mg/day, Period2:K-877 CR 0.8 mg/day (pre-meal)
Arm Title
Treatment D
Arm Type
Experimental
Arm Description
Period1:K-877 IR 0.2 mg/day, Period2:K-877 CR 0.8 mg/day (postprandial)
Arm Title
Treatment E
Arm Type
Experimental
Arm Description
Period1:K-877 CR 0.4 mg/day, Period2:K-877 IR 0.2 mg/day (pre-meal)
Arm Title
Treatment F
Arm Type
Experimental
Arm Description
Period1:K-877 CR 0.4 mg/day, Period2:K-877 IR 0.2 mg/day (postprandial)
Arm Title
Treatment G
Arm Type
Experimental
Arm Description
Period1:K-877 CR 0.4 mg/day, Period2:K-877 CR 0.8 mg/day (pre-meal)
Arm Title
Treatment H
Arm Type
Experimental
Arm Description
Period1:K-877 CR 0.4 mg/day, Period2:K-877 CR 0.8 mg/day (postprandial)
Arm Title
Treatment I
Arm Type
Experimental
Arm Description
Period1:K-877 CR 0.8 mg/day, Period2:K-877 IR 0.2 mg/day (pre-meal)
Arm Title
Treatment J
Arm Type
Experimental
Arm Description
Period1:K-877 CR 0.8 mg/day, Period2:K-877 IR 0.2 mg/day (postprandial)
Arm Title
Treatment K
Arm Type
Experimental
Arm Description
Period1:K-877 CR 0.8 mg/day, Period2:K-877 CR 0.4 mg/day (pre-meal)
Arm Title
Treatment L
Arm Type
Experimental
Arm Description
Period1:K-877 CR 0.8 mg/day, Period2:K-877 CR 0.4 mg/day (postprandial)
Intervention Type
Drug
Intervention Name(s)
K-877 IR 0.2 mg/day
Other Intervention Name(s)
Pemafibrate
Intervention Description
K-877 IR 0.1 mg tablet
Intervention Type
Drug
Intervention Name(s)
K-877 CR 0.4 mg/day
Other Intervention Name(s)
Pemafibrate
Intervention Description
K-877 CR 0.4 mg tablet
Intervention Type
Drug
Intervention Name(s)
K-877 CR 0.8 mg/day
Other Intervention Name(s)
Pemafibrate
Intervention Description
Two K-877 CR 0.4 mg tablet
Primary Outcome Measure Information:
Title
Efficacy: % change from baseline in fasting serum TG(mg/dL)
Time Frame
4 week after administration in each period
Secondary Outcome Measure Information:
Title
% change from baseline in fasting HDL-C levels(mg/dL)
Time Frame
4 week after administration in each period
Title
% change from baseline in fasting LDL-C levels(mg/dL)
Time Frame
4 week after administration in each period
Title
% change from baseline in fasting non-HDL-C levels(mg/dL)
Time Frame
4 week after administration in each period
Title
% change from baseline in fasting Total Cholesterol levels(mg/dL)
Time Frame
4 week after administration in each period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Medical Corporation Heishinkai OPHAC Hospital
City
Osaka
ZIP/Postal Code
532-0003
Country
Japan
12. IPD Sharing Statement
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A Clinical Pharmacology Study of K-877 Controlled Release Tablet
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