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A study to compare the efficacy, safety, and pharmacokinetics of K-877 controlled release tablets with a current normal K-877 tablet in dyslipidemia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Experimental | Period1:K-877 IR 0.2 mg/day, Period2:K-877 CR 0.4 mg/day (pre-meal) |
|
| Treatment B | Experimental | Period1:K-877 IR 0.2 mg/day, Period2:K-877 CR 0.4 mg/day (postprandial) |
|
| Treatment C | Experimental | Period1:K-877 IR 0.2 mg/day, Period2:K-877 CR 0.8 mg/day (pre-meal) |
|
| Treatment D | Experimental | Period1:K-877 IR 0.2 mg/day, Period2:K-877 CR 0.8 mg/day (postprandial) |
|
| Treatment E | Experimental | Period1:K-877 CR 0.4 mg/day, Period2:K-877 IR 0.2 mg/day (pre-meal) |
|
| Treatment F |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| K-877 IR 0.2 mg/day | Drug | K-877 IR 0.1 mg tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy: % change from baseline in fasting serum TG(mg/dL) | 4 week after administration in each period |
| Measure | Description | Time Frame |
|---|---|---|
| % 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Corporation Heishinkai OPHAC Hospital | Osaka | 532-0003 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39322570 | Result | 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. |
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| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C540740 | (R)-2-(3-((benzoxazol-2-yl-d4 (3-(4-methoxyphenoxy-d7)propyl)amino)methyl)phenoxy) butanoic acid |
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| Experimental |
Period1:K-877 CR 0.4 mg/day, Period2:K-877 IR 0.2 mg/day (postprandial) |
|
| Treatment G | Experimental | Period1:K-877 CR 0.4 mg/day, Period2:K-877 CR 0.8 mg/day (pre-meal) |
|
| Treatment H | Experimental | Period1:K-877 CR 0.4 mg/day, Period2:K-877 CR 0.8 mg/day (postprandial) |
|
| Treatment I | Experimental | Period1:K-877 CR 0.8 mg/day, Period2:K-877 IR 0.2 mg/day (pre-meal) |
|
| Treatment J | Experimental | Period1:K-877 CR 0.8 mg/day, Period2:K-877 IR 0.2 mg/day (postprandial) |
|
| Treatment K | Experimental | Period1:K-877 CR 0.8 mg/day, Period2:K-877 CR 0.4 mg/day (pre-meal) |
|
| Treatment L | Experimental | Period1:K-877 CR 0.8 mg/day, Period2:K-877 CR 0.4 mg/day (postprandial) |
|
|
| K-877 CR 0.4 mg/day | Drug | K-877 CR 0.4 mg tablet |
|
|
| K-877 CR 0.8 mg/day | Drug | Two K-877 CR 0.4 mg tablet |
|
|
| % 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 |