A Clinical Pharmacology Study of K-877 Controlled Release Tablet
NCT ID: NCT04079530
Last Updated: 2025-10-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
60 participants
INTERVENTIONAL
2019-09-13
2019-12-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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Treatment A
Period1:K-877 IR 0.2 mg/day, Period2:K-877 CR 0.4 mg/day (pre-meal)
K-877 IR 0.2 mg/day
K-877 IR 0.1 mg tablet
K-877 CR 0.4 mg/day
K-877 CR 0.4 mg tablet
Treatment B
Period1:K-877 IR 0.2 mg/day, Period2:K-877 CR 0.4 mg/day (postprandial)
K-877 IR 0.2 mg/day
K-877 IR 0.1 mg tablet
K-877 CR 0.4 mg/day
K-877 CR 0.4 mg tablet
Treatment C
Period1:K-877 IR 0.2 mg/day, Period2:K-877 CR 0.8 mg/day (pre-meal)
K-877 IR 0.2 mg/day
K-877 IR 0.1 mg tablet
K-877 CR 0.8 mg/day
Two K-877 CR 0.4 mg tablet
Treatment D
Period1:K-877 IR 0.2 mg/day, Period2:K-877 CR 0.8 mg/day (postprandial)
K-877 IR 0.2 mg/day
K-877 IR 0.1 mg tablet
K-877 CR 0.8 mg/day
Two K-877 CR 0.4 mg tablet
Treatment E
Period1:K-877 CR 0.4 mg/day, Period2:K-877 IR 0.2 mg/day (pre-meal)
K-877 IR 0.2 mg/day
K-877 IR 0.1 mg tablet
K-877 CR 0.4 mg/day
K-877 CR 0.4 mg tablet
Treatment F
Period1:K-877 CR 0.4 mg/day, Period2:K-877 IR 0.2 mg/day (postprandial)
K-877 IR 0.2 mg/day
K-877 IR 0.1 mg tablet
K-877 CR 0.4 mg/day
K-877 CR 0.4 mg tablet
Treatment G
Period1:K-877 CR 0.4 mg/day, Period2:K-877 CR 0.8 mg/day (pre-meal)
K-877 CR 0.4 mg/day
K-877 CR 0.4 mg tablet
K-877 CR 0.8 mg/day
Two K-877 CR 0.4 mg tablet
Treatment H
Period1:K-877 CR 0.4 mg/day, Period2:K-877 CR 0.8 mg/day (postprandial)
K-877 CR 0.4 mg/day
K-877 CR 0.4 mg tablet
K-877 CR 0.8 mg/day
Two K-877 CR 0.4 mg tablet
Treatment I
Period1:K-877 CR 0.8 mg/day, Period2:K-877 IR 0.2 mg/day (pre-meal)
K-877 IR 0.2 mg/day
K-877 IR 0.1 mg tablet
K-877 CR 0.8 mg/day
Two K-877 CR 0.4 mg tablet
Treatment J
Period1:K-877 CR 0.8 mg/day, Period2:K-877 IR 0.2 mg/day (postprandial)
K-877 IR 0.2 mg/day
K-877 IR 0.1 mg tablet
K-877 CR 0.8 mg/day
Two K-877 CR 0.4 mg tablet
Treatment K
Period1:K-877 CR 0.8 mg/day, Period2:K-877 CR 0.4 mg/day (pre-meal)
K-877 CR 0.4 mg/day
K-877 CR 0.4 mg tablet
K-877 CR 0.8 mg/day
Two K-877 CR 0.4 mg tablet
Treatment L
Period1:K-877 CR 0.8 mg/day, Period2:K-877 CR 0.4 mg/day (postprandial)
K-877 CR 0.4 mg/day
K-877 CR 0.4 mg tablet
K-877 CR 0.8 mg/day
Two K-877 CR 0.4 mg tablet
Interventions
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K-877 IR 0.2 mg/day
K-877 IR 0.1 mg tablet
K-877 CR 0.4 mg/day
K-877 CR 0.4 mg tablet
K-877 CR 0.8 mg/day
Two K-877 CR 0.4 mg tablet
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
20 Years
ALL
No
Sponsors
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Kowa Company, Ltd.
INDUSTRY
Responsible Party
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Locations
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Medical Corporation Heishinkai OPHAC Hospital
Osaka, , Japan
Countries
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References
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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.
Other Identifiers
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K-877-CR-01
Identifier Type: -
Identifier Source: org_study_id
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