A Clinical Pharmacology Study of K-877 Controlled Release Tablet

Kowa

Status and phase: Completed; Phase 2

Conditions: Dyslipidemias

Treatments: Drug: K-877 CR 0.8 mg/day; Drug: K-877 IR 0.2 mg/day; Drug: K-877 CR 0.4 mg/day

Study type: Interventional

Funder types: Industry

Identifiers

NCT04079530

K-877-CR-01

Details and patient eligibility

About

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

Enrollment: 60 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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60 participants in 12 patient groups

Treatment A

Experimental group

Description:

Period1:K-877 IR 0.2 mg/day, Period2:K-877 CR 0.4 mg/day (pre-meal)

Treatment:

Drug: K-877 CR 0.4 mg/day

Drug: K-877 IR 0.2 mg/day

Treatment B

Experimental group

Description:

Period1:K-877 IR 0.2 mg/day, Period2:K-877 CR 0.4 mg/day (postprandial)

Treatment:

Drug: K-877 CR 0.4 mg/day

Drug: K-877 IR 0.2 mg/day

Treatment C

Experimental group

Description:

Period1:K-877 IR 0.2 mg/day, Period2:K-877 CR 0.8 mg/day (pre-meal)

Treatment:

Drug: K-877 IR 0.2 mg/day

Drug: K-877 CR 0.8 mg/day

Treatment D

Experimental group

Description:

Period1:K-877 IR 0.2 mg/day, Period2:K-877 CR 0.8 mg/day (postprandial)

Treatment:

Drug: K-877 IR 0.2 mg/day

Drug: K-877 CR 0.8 mg/day

Treatment E

Experimental group

Description:

Period1:K-877 CR 0.4 mg/day, Period2:K-877 IR 0.2 mg/day (pre-meal)

Treatment:

Drug: K-877 CR 0.4 mg/day

Drug: K-877 IR 0.2 mg/day

Treatment F

Experimental group

Description:

Period1:K-877 CR 0.4 mg/day, Period2:K-877 IR 0.2 mg/day (postprandial)

Treatment:

Drug: K-877 CR 0.4 mg/day

Drug: K-877 IR 0.2 mg/day

Treatment G

Experimental group

Description:

Period1:K-877 CR 0.4 mg/day, Period2:K-877 CR 0.8 mg/day (pre-meal)

Treatment:

Drug: K-877 CR 0.4 mg/day

Drug: K-877 CR 0.8 mg/day

Treatment H

Experimental group

Description:

Period1:K-877 CR 0.4 mg/day, Period2:K-877 CR 0.8 mg/day (postprandial)

Treatment:

Drug: K-877 CR 0.4 mg/day

Drug: K-877 CR 0.8 mg/day

Treatment I

Experimental group

Description:

Period1:K-877 CR 0.8 mg/day, Period2:K-877 IR 0.2 mg/day (pre-meal)

Treatment:

Drug: K-877 IR 0.2 mg/day

Drug: K-877 CR 0.8 mg/day

Treatment J

Experimental group

Description:

Period1:K-877 CR 0.8 mg/day, Period2:K-877 IR 0.2 mg/day (postprandial)

Treatment:

Drug: K-877 IR 0.2 mg/day

Drug: K-877 CR 0.8 mg/day

Treatment K

Experimental group

Description:

Period1:K-877 CR 0.8 mg/day, Period2:K-877 CR 0.4 mg/day (pre-meal)

Treatment:

Drug: K-877 CR 0.4 mg/day

Drug: K-877 CR 0.8 mg/day

Treatment L

Experimental group

Description:

Period1:K-877 CR 0.8 mg/day, Period2:K-877 CR 0.4 mg/day (postprandial)

Treatment:

Drug: K-877 CR 0.4 mg/day

Drug: K-877 CR 0.8 mg/day