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A Clinical Pharmacology Study of K-877 Controlled Release Tablet

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ClinicalTrials.gov Identifier: NCT04079530
Recruitment Status : Not yet recruiting
First Posted : September 5, 2019
Last Update Posted : September 5, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Dyslipidemias Drug: K-877 IR 0.2 mg/day Drug: K-877 CR 0.4 mg/day Drug: K-877 CR 0.8 mg/day Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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
Estimated Study Start Date : September 21, 2019
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

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 Name: Pemafibrate

Drug: K-877 CR 0.4 mg/day
K-877 CR 0.4 mg tablet
Other Name: 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 Name: Pemafibrate

Drug: K-877 CR 0.4 mg/day
K-877 CR 0.4 mg tablet
Other Name: 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 Name: Pemafibrate

Drug: K-877 CR 0.8 mg/day
Two K-877 CR 0.4 mg tablet
Other Name: 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 Name: Pemafibrate

Drug: K-877 CR 0.8 mg/day
Two K-877 CR 0.4 mg tablet
Other Name: 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 Name: Pemafibrate

Drug: K-877 CR 0.4 mg/day
K-877 CR 0.4 mg tablet
Other Name: 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 Name: Pemafibrate

Drug: K-877 CR 0.4 mg/day
K-877 CR 0.4 mg tablet
Other Name: 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 Name: Pemafibrate

Drug: K-877 CR 0.8 mg/day
Two K-877 CR 0.4 mg tablet
Other Name: 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 Name: Pemafibrate

Drug: K-877 CR 0.8 mg/day
Two K-877 CR 0.4 mg tablet
Other Name: 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 Name: Pemafibrate

Drug: K-877 CR 0.8 mg/day
Two K-877 CR 0.4 mg tablet
Other Name: 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 Name: Pemafibrate

Drug: K-877 CR 0.8 mg/day
Two K-877 CR 0.4 mg tablet
Other Name: 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 Name: Pemafibrate

Drug: K-877 CR 0.8 mg/day
Two K-877 CR 0.4 mg tablet
Other Name: 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 Name: Pemafibrate

Drug: K-877 CR 0.8 mg/day
Two K-877 CR 0.4 mg tablet
Other Name: Pemafibrate




Primary Outcome Measures :
  1. Efficacy: % change from baseline in fasting serum TG(mg/dL) [ Time Frame: 4 week after administration in each period ]

Secondary Outcome Measures :
  1. % change from baseline in fasting HDL-C levels(mg/dL) [ Time Frame: 4 week after administration in each period ]
  2. % change from baseline in fasting LDL-C levels(mg/dL) [ Time Frame: 4 week after administration in each period ]
  3. % change from baseline in fasting non-HDL-C levels(mg/dL) [ Time Frame: 4 week after administration in each period ]
  4. % change from baseline in fasting Total Cholesterol levels(mg/dL) [ Time Frame: 4 week after administration in each period ]


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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Responsible Party: Kowa Company, Ltd.
ClinicalTrials.gov Identifier: NCT04079530     History of Changes
Other Study ID Numbers: K-877-CR-01
First Posted: September 5, 2019    Key Record Dates
Last Update Posted: September 5, 2019
Last Verified: September 2019

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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
Additional relevant MeSH terms:
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Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases