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

Start Date25 Sep 2020

Sponsor / Collaborator

Chong Kun Dang Pharmaceutical Corp.

NCT03558425 / CompletedPhase 1

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

Start Date27 Jun 2018

Sponsor / Collaborator

Chong Kun Dang Pharmaceutical Corp.

NCT01675154 / TerminatedPhase 2IIT

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.

Start Date01 Nov 2015

Sponsor / Collaborator

The University of Texas Southwestern Medical Center

100 Clinical Results associated with KD-026

100 Translational Medicine associated with KD-026

100 Patents (Medical) associated with KD-026

Literatures (Medical) associated with KD-026

01 Jun 2011·Journal of Pharmacology and Experimental TherapeuticsQ3 · MEDICINE

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

Q3 · MEDICINE

Article

Author: 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 Deals associated with KD-026

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB05678

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Diabetes Mellitus, Type 2	Phase 2	-	Kadmon Holdings, Inc.	-
Hypertriglyceridemia	Phase 2	-	Kadmon Holdings, Inc.	-
Hyperlipoproteinemia Type I	Preclinical	US	The University of Texas Southwestern Medical Center	01 Nov 2015
Dyslipidemias	Preclinical	US	Kadmon Pharmaceuticals LLC	-
Dyslipidemias	Preclinical	DE	Kadmon Pharmaceuticals LLC	-
Obesity	Preclinical	US	Kadmon Pharmaceuticals LLC	-
Hyperlipidemias	Discovery	US	Response Pharmaceuticals, Inc.	01 Jan 2009

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