A Randomized, Open-label, Crossover Phase 1 Clinical Trial to Compare Pharmaciokinetics, Pharmacodynamics and Safetry After Single/ Multiple Administration of CKD-382 and D026 in Healthy Subjects

To compare pharmacokinetics, pharmacodynamics and safety after single/multiple administration of CKD-382 and D026 in healthy subjects

开始日期2020-09-25

申办/合作机构

Chong Kun Dang Pharmaceutical Corp.

NCT03558425 / Completed临床1期

A Randomized, Open-label, Multiple-dose, and Crossover Study to Compare Pharmacokinetics, Pharmacodynamics and Safety of CKD-381 and D026 in Healthy Subjects

A Study to compare pharmacokinetics and safety of CKD-381 and D026 in healthy subjects

开始日期2018-06-27

申办/合作机构

Chong Kun Dang Pharmaceutical Corp.

NCT01675154 / Terminated临床2期IIT

Phase 2 Study of Orlistat and SLx-4090 for the Treatment of Type 1 Hyperlipoproteinemia

Funding Source - FDA OOPD
This study is being done to find out whether an investigational (not approved by FDA ) drug called SLx-4090 or Orlistat (FDA approved medication for weight loss) when given alone or in combination can treat the high blood fat (elevated triglycerides)levels found in the condition Type 1 Hyperlipoproteinemia (T1HLP) better or more safely than low fat diet alone, the current standard medical care.
It is also not clear whether Orlistat, that is FDA approved for weight loss, is effective in lowering blood fat levels in patients with Type 1 hyperlipoproteinemia (T1HLP). The researchers are interested in learning whether any one of these drugs when given alone or in combination is more effective and safe in treating T1HLP.

开始日期2015-11-01

申办/合作机构

The University of Texas Southwestern Medical Center

100 项与 KD-026 相关的临床结果

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100 项与 KD-026 相关的转化医学

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100 项与 KD-026 相关的专利（医药）

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项与 KD-026 相关的文献（医药）

2011-06-01·Journal of Pharmacology and Experimental Therapeutics3区 · 医学

A Small-Molecule Inhibitor of Enterocytic Microsomal Triglyceride Transfer Protein, SLx-4090: Biochemical, Pharmacodynamic, Pharmacokinetic, and Safety Profile

3区 · 医学

Article

作者: Schueller, Olivier ; Kuo, Jay ; Sweetnam, Paul ; Kim, Enoch ; Ferkany, John ; Cole, Bridget ; Ellis, James ; Wong, Eric ; Campbell, Stewart

First-generation microsomal triglyceride transfer protein (MTP) inhibitors were designed to inhibit hepatic MTP and provide a novel treatment of dyslipidemia. Effective at lowering low-density lipoprotein-cholesterol (LDL-C), these inhibitors also elevate liver enzymes and induce hepatic steatosis in animals and humans. MTP is highly expressed in the enterocytes, lining the lumen of the jejunum, and is critical in the production of chylomicrons assembled from lipid/cholesterol and their transfer into systemic circulation. 6-(4'-Trifluoromethyl-6-methoxy-biphenyl-2-ylcarboxamido)-1,2,3,4-tetrahydroisoquinoline-2-carboxylic acid phenyl ester (SLx-4090) (IC(50) value ∼8 nM) was designed to inhibit only MTP localized to enterocytes. In Caco-2 cells SLx-4090 inhibited apolipoprotein B (IC(50) value ∼9.6 nM) but not apolipoprotein A1 secretion. Administered orally to rats SLx-4090 reduced postprandial lipids by >50% with an ED(50) value ∼7 mg/kg. SLx-4090 was not detected in the systemic or portal vein serum of the animals (lower limit of quantitation ∼5 ng/ml) after single or multiple oral doses in fasted rodents. When coadministered with tyloxapol, SLx-4090 did not inhibit the secretion of hepatic triglycerides (TG), consistent with the absence of systemic exposure. Chronic treatment with SLx-4090 in mice maintained on a high-fat diet decreased LDL-C and TG and resulted in weight loss without the elevation of liver enzymes or an increase in hepatic fat. The compound did not result in toxicity when administered to rats for 90 days at a dose of 1000 mg/kg per day. These data support the concept that the inhibition of enterocytic MTP could serve as a useful strategy in the treatment of metabolic disorders.

100 项与 KD-026 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB05678

研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
I型高脂蛋白血症	临床3期	美国	The University of Texas Southwestern Medical Center	2015-11-01
血脂障碍	临床3期	美国	Kadmon Pharmaceuticals LLC	-
血脂障碍	临床3期	德国	Kadmon Pharmaceuticals LLC	-
肥胖	临床3期	美国	Kadmon Pharmaceuticals LLC	-
2型糖尿病	临床2期	-	Kadmon Holdings, Inc.	-
高甘油三酯血症	临床2期	-	Kadmon Holdings, Inc.	-
高脂血症	临床前	美国	Response Pharmaceuticals, Inc.	2009-01-01