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Tesaglitazar, a PPARalpha/gamma agonist, induces interstitial mesenchymal cell DNA synthesis and fibrosarcomas in subcutaneous tissues in rats.
TLDR
The results suggest that the induction of rat fibrosarcoma by tesaglitazar, at exposures 100-fold above the human therapeutic exposure, may involve proliferation of undifferentiated mesenchymal cells in subcutaneous tissues. Expand
Tesaglitazar, a PPARα/γ Agonist, Induces Interstitial Mesenchymal Cell DNA Synthesis and Fibrosarcomas in Subcutaneous Tissues in Rats
TLDR
The results suggest that the induction of rat fibrosarcoma by tesaglitazar, at exposures 100-fold above the human therapeutic exposure, may involve proliferation of undifferentiated mesenchymal cells in subcutaneous tissues. Expand
Multiple Compound-Related Adverse Properties Contribute to Liver Injury Caused by Endothelin Receptor Antagonists
TLDR
The data indicate that multiple mechanisms contribute to the rare, but potentially severe liver injury caused by sitaxentan in humans; provide a plausible rationale for the markedly lower propensity of bosentan to cause liver injury; and highlight the relative safety of ambrisentan. Expand
Pharmacokinetics and metabolism of tesaglitazar, a novel dual-acting peroxisome proliferator-activated receptor alpha/gamma agonist, after a single oral and intravenous dose in humans.
TLDR
The pharmacokinetics of tesaglitazar (GALIDA), a novel dual-acting peroxisome proliferator-activated receptor alpha and gamma agonist, were studied in eight healthy male subjects, indicating low systemic metabolite concentrations and formation rate limitation of metabolite elimination. Expand
Effects of Tenapanor on Cytochrome P450‐Mediated Drug‐Drug Interactions
TLDR
It is suggested that tenapanor can be coadministered with CYP3A4‐metabolized drugs without affecting their exposure and found findings were similar for metabolites of midazolam. Expand
Effect of broad-spectrum matrix metalloproteinase inhibition on atherosclerotic plaque stability.
TLDR
The data suggest that broad-spectrum MMP inhibition RS-130830 does not have a beneficial effect on atherosclerosis in the apolipoprotein E knockout mouse model, and indicate that more selective compounds would be preferable. Expand
Drug metabolism and pharmacokinetic strategies for oligonucleotide- and mRNA-based drug development.
TLDR
There is a need for nonclinical regulatory guidance to address these new modalities and the scalability and translatability between species and compound properties is crucial for robust nonclinical PKPD predictions to support clinical study design. Expand
Abstract 13307: An Oral Antisense Oligonucleotide for PCSK9 Inhibition in Humans
TLDR
A highly potent, chemically modified PCSK9 antisense oligonucleotide (ASO) with potential for oral deliverence inoters is presented. Expand
An oral antisense oligonucleotide for PCSK9 inhibition
TLDR
A highly potent, chemically modified PCSK9 antisense oligonucleotide formulated with a permeation enhancer that can be delivered orally, is taken up by the liver, and targetsPCSK9, which regulates the LDL receptor is developed. Expand
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