A Clinical Pharmacology Study of K-877 Controlled Release Tablet

April 8, 2021 updated by: Kowa Company, Ltd.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Osaka, Japan, 532-0003
        • Medical Corporation Heishinkai OPHAC Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment A
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
K-877 IR 0.1 mg tablet
Other Names:
  • Pemafibrate
Drug: K-877 CR 0.4 mg/day
K-877 CR 0.4 mg tablet
Other Names:
  • Pemafibrate
Experimental: Treatment B
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
K-877 IR 0.1 mg tablet
Other Names:
  • Pemafibrate
Drug: K-877 CR 0.4 mg/day
K-877 CR 0.4 mg tablet
Other Names:
  • Pemafibrate
Experimental: Treatment C
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
K-877 IR 0.1 mg tablet
Other Names:
  • Pemafibrate
Drug: K-877 CR 0.8 mg/day
Two K-877 CR 0.4 mg tablet
Other Names:
  • Pemafibrate
Experimental: Treatment D
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
K-877 IR 0.1 mg tablet
Other Names:
  • Pemafibrate
Drug: K-877 CR 0.8 mg/day
Two K-877 CR 0.4 mg tablet
Other Names:
  • Pemafibrate
Experimental: Treatment E
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
K-877 IR 0.1 mg tablet
Other Names:
  • Pemafibrate
Drug: K-877 CR 0.4 mg/day
K-877 CR 0.4 mg tablet
Other Names:
  • Pemafibrate
Experimental: Treatment F
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
K-877 IR 0.1 mg tablet
Other Names:
  • Pemafibrate
Drug: K-877 CR 0.4 mg/day
K-877 CR 0.4 mg tablet
Other Names:
  • Pemafibrate
Experimental: Treatment G
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
K-877 CR 0.4 mg tablet
Other Names:
  • Pemafibrate
Drug: K-877 CR 0.8 mg/day
Two K-877 CR 0.4 mg tablet
Other Names:
  • Pemafibrate
Experimental: Treatment H
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
K-877 CR 0.4 mg tablet
Other Names:
  • Pemafibrate
Drug: K-877 CR 0.8 mg/day
Two K-877 CR 0.4 mg tablet
Other Names:
  • Pemafibrate
Experimental: Treatment I
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
K-877 IR 0.1 mg tablet
Other Names:
  • Pemafibrate
Drug: K-877 CR 0.8 mg/day
Two K-877 CR 0.4 mg tablet
Other Names:
  • Pemafibrate
Experimental: Treatment J
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
K-877 IR 0.1 mg tablet
Other Names:
  • Pemafibrate
Drug: K-877 CR 0.8 mg/day
Two K-877 CR 0.4 mg tablet
Other Names:
  • Pemafibrate
Experimental: Treatment K
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
K-877 CR 0.4 mg tablet
Other Names:
  • Pemafibrate
Drug: K-877 CR 0.8 mg/day
Two K-877 CR 0.4 mg tablet
Other Names:
  • Pemafibrate
Experimental: Treatment L
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
K-877 CR 0.4 mg tablet
Other Names:
  • Pemafibrate
Drug: K-877 CR 0.8 mg/day
Two K-877 CR 0.4 mg tablet
Other Names:
  • Pemafibrate

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
% change from baseline in fasting HDL-C levels(mg/dL)
Time Frame: 4 week after administration in each period
4 week after administration in each period
% change from baseline in fasting LDL-C levels(mg/dL)
Time Frame: 4 week after administration in each period
4 week after administration in each period
% change from baseline in fasting non-HDL-C levels(mg/dL)
Time Frame: 4 week after administration in each period
4 week after administration in each period
% change from baseline in fasting Total Cholesterol levels(mg/dL)
Time Frame: 4 week after administration in each period
4 week after administration in each period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kowa Company, Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 13, 2019

Primary Completion (Actual)

December 24, 2019

Study Completion (Actual)

March 31, 2020

Study Registration Dates

First Submitted

September 3, 2019

First Submitted That Met QC Criteria

September 4, 2019

First Posted (Actual)

September 6, 2019

Study Record Updates

Last Update Posted (Actual)

April 9, 2021

Last Update Submitted That Met QC Criteria

April 8, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K-877-CR-01

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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