A Clinical Pharmacology Study of K-877 Controlled Release Tablet
Study Details
Study Description
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 |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| 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:
Drug: K-877 CR 0.4 mg/day
K-877 CR 0.4 mg tablet
Other Names:
|
| 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:
Drug: K-877 CR 0.4 mg/day
K-877 CR 0.4 mg tablet
Other Names:
|
| 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:
Drug: K-877 CR 0.8 mg/day
Two K-877 CR 0.4 mg tablet
Other Names:
|
| 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:
Drug: K-877 CR 0.8 mg/day
Two K-877 CR 0.4 mg tablet
Other Names:
|
| 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:
Drug: K-877 CR 0.4 mg/day
K-877 CR 0.4 mg tablet
Other Names:
|
| 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:
Drug: K-877 CR 0.4 mg/day
K-877 CR 0.4 mg tablet
Other Names:
|
| 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:
Drug: K-877 CR 0.8 mg/day
Two K-877 CR 0.4 mg tablet
Other Names:
|
| 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:
Drug: K-877 CR 0.8 mg/day
Two K-877 CR 0.4 mg tablet
Other Names:
|
| 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:
Drug: K-877 CR 0.8 mg/day
Two K-877 CR 0.4 mg tablet
Other Names:
|
| 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:
Drug: K-877 CR 0.8 mg/day
Two K-877 CR 0.4 mg tablet
Other Names:
|
| 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:
Drug: K-877 CR 0.8 mg/day
Two K-877 CR 0.4 mg tablet
Other Names:
|
| 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:
Drug: K-877 CR 0.8 mg/day
Two K-877 CR 0.4 mg tablet
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Efficacy: % change from baseline in fasting serum TG(mg/dL) [4 week after administration in each period]
Secondary Outcome Measures
- % 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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.
Exclusion Criteria:
-
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Medical Corporation Heishinkai OPHAC Hospital | Osaka | Japan | 532-0003 |
Sponsors and Collaborators
- Kowa Company, Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- K-877-CR-01