A Clinical Pharmacology Study of K-877 Controlled Release Tablet

NCT04079530 | Completed Phase 2

• 1 other identifier: K-877-CR-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Dyslipidemias

Outcome Measures

Primary Outcomes (1)

• Efficacy: % change from baseline in fasting serum TG(mg/dL)

  4 week after administration in each period

Secondary Outcomes (4)

• % 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

Study Arms (12)

Treatment A

EXPERIMENTAL

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; Drug: K-877 CR 0.4 mg/day

Treatment B

EXPERIMENTAL

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; Drug: K-877 CR 0.4 mg/day

Treatment C

EXPERIMENTAL

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; Drug: K-877 CR 0.8 mg/day

Treatment D

EXPERIMENTAL

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; Drug: K-877 CR 0.8 mg/day

Treatment E

EXPERIMENTAL

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; Drug: K-877 CR 0.4 mg/day

Treatment F

EXPERIMENTAL

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; Drug: K-877 CR 0.4 mg/day

Treatment G

EXPERIMENTAL

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; Drug: K-877 CR 0.8 mg/day

Treatment H

EXPERIMENTAL

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; Drug: K-877 CR 0.8 mg/day

Treatment I

EXPERIMENTAL

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; Drug: K-877 CR 0.8 mg/day

Treatment J

EXPERIMENTAL

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; Drug: K-877 CR 0.8 mg/day

Treatment K

EXPERIMENTAL

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; Drug: K-877 CR 0.8 mg/day

Treatment L

EXPERIMENTAL

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; Drug: K-877 CR 0.8 mg/day

Interventions

K-877 IR 0.2 mg/day DRUG

K-877 IR 0.1 mg tablet

Also known as: Pemafibrate

Treatment A; Treatment B; Treatment C; Treatment D; Treatment E; Treatment F; Treatment I; Treatment J

K-877 CR 0.4 mg/day DRUG

K-877 CR 0.4 mg tablet

Also known as: Pemafibrate

Treatment A; Treatment B; Treatment E; Treatment F; Treatment G; Treatment H; Treatment K; Treatment L

K-877 CR 0.8 mg/day DRUG

Two K-877 CR 0.4 mg tablet

Also known as: Pemafibrate

Treatment C; Treatment D; Treatment G; Treatment H; Treatment I; Treatment J; Treatment K; Treatment L

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Kowa Company, Ltd.: lead

Study Sites (1)

Medical Corporation Heishinkai OPHAC Hospital

Osaka, 532-0003, Japan

Location

Related Publications (1)

• Yamashita S, Araki E, Arai H, Yokote K, Tanigawa R, Saito A, Suganami H, Minamikawa S, Ishibashi S. Clinical Pharmacology of Pemafibrate Extended-release Formulation in Patients with Hypertriglyceridemia-A Phase 2, Multicenter, Active-controlled, Randomized, Single-blind, Crossover study. J Atheroscler Thromb. 2025 Mar 1;32(3):367-384. doi: 10.5551/jat.65001. Epub 2024 Sep 26.

  PMID: 39322570 RESULT

MeSH Terms

Conditions

Dyslipidemias

Interventions

(R)-2-(3-((benzoxazol-2-yl-d4 (3-(4-methoxyphenoxy-d7)propyl)amino)methyl)phenoxy) butanoic acid

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2019
• First Posted: September 6, 2019
• Study Start: September 13, 2019
• Primary Completion: December 24, 2019
• Study Completion: December 24, 2019
• Last Updated: October 6, 2025

Record last verified: 2025-09

Locations

JP (1)