Výsledky vyhledávání - "Winnie, Sohn"

Akademický článek

Evaluation of drug‐drug interaction potential between omecamtiv mecarbil and rosuvastatin, a BCRP substrate, with a clinical study in healthy subjects and using a physiologically‐based pharmacokinetic model

Autor: Ashit Trivedi, Winnie Sohn, Priyanka Kulkarni, Pegah Jafarinasabian, Hanze Zhang, Marintan Spring, Stephen Flach, Siddique Abbasi, Jan Wahlstrom, Edward Lee, Sandeep Dutta

Publikováno v: Clinical and Translational Science, Vol 14, Iss 6, Pp 2510-2520 (2021)

Abstract Omecamtiv mecarbil (OM) is a novel cardiac myosin activator in development for the treatment of heart failure. In vitro, OM is an inhibitor of BCRP. Rosuvastatin, a BCRP substrate, is one of the most commonly prescribed medications in patien

Externí odkaz: https://doaj.org/article/86aa2e97af2349d6999630760b8de569

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Pharmacokinetics, Pharmacodynamics, and Tolerability of Olpasiran in Healthy Japanese and Non-Japanese Participants: Results from a Phase I, Single-dose, Open-label Study

Autor: Winnie, Sohn, Peter, Winkle, Joel, Neutel, You, Wu, Freeman, Jabari, Caitlin, Terrio, Tracy, Varrieur, Jingying, Wang, Jennifer, Hellawell

Publikováno v: Clinical Therapeutics. 44:1237-1247

Olpasiran, an N-acetyl galactosamine-conjugated, hepatocyte-targeted, small interfering RNA, is being developed to reduce plasma lipoprotein (Lp)-(a) concentration by directly targeting the LPA gene. This study evaluated the pharmacokinetics, pharmac

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::9f472cba1221eec211a080db8b6d827c
https://doi.org/10.1016/j.clinthera.2022.07.008

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Preclinical development and phase 1 trial of a novel siRNA targeting lipoprotein(a)

Autor: Michael J. Koren, Patrick Maurice Moriarty, Seth J. Baum, Joel Neutel, Martha Hernandez-Illas, Howard S. Weintraub, Monica Florio, Helina Kassahun, Stacey Melquist, Tracy Varrieur, Saptarsi M. Haldar, Winnie Sohn, Huei Wang, Mary Elliott-Davey, Brooke M. Rock, Tao Pei, Oliver Homann, Jennifer Hellawell, Gerald F. Watts

Publikováno v: Nature Medicine. 28:96-103

Compelling evidence supports a causal role for lipoprotein(a) (Lp(a)) in cardiovascular disease. No pharmacotherapies directly targeting Lp(a) are currently available for clinical use. Here we report the discovery and development of olpasiran, a firs

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::678f185b03c180f42d8ec3d9c920d969
https://doi.org/10.1038/s41591-021-01634-w

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A Phase I, Multiple-Dose, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Pharmacokinetics, Safety, and Tolerability of Etelcalcetide Administered Intravenously to Chinese Patients With Chronic Kidney Disease Undergoing Hemodialysis

Autor: Xiaoqiang Ding, Zhaohui Ni, Carol Kong, Hong Lu, Jennifer Hellawell, Changying Xing, Jing Chen, Li Zuo, Winnie Sohn, Guiling Shi, Sunfa Cheng, Yi Fang

Publikováno v: Clinical Therapeutics. 43:2013-2023

Purpose This study reports data from the first evaluation of etelcalcetide treatment in Chinese adults with chronic kidney disease and secondary hyperparathyroidism. Methods This phase I, randomized study compared thrice-weekly etelcalcetide (5 mg pe

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::1f71a7671c01e11756afbddbd4d8c82c
https://doi.org/10.1016/j.clinthera.2021.09.019

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Autor: Winnie Sohn, Jan Wahlstrom, Marintan Spring, Hanze Zhang, Siddique Abbasi, Stephen Flach, Sandeep Dutta, Priyanka Kulkarni, Ashit Trivedi, Edward Lee, Pegah Jafarinasabian

Publikováno v: Clinical and Translational Science
Clinical and Translational Science, Vol 14, Iss 6, Pp 2510-2520 (2021)

Omecamtiv mecarbil (OM) is a novel cardiac myosin activator in development for the treatment of heart failure. In vitro, OM is an inhibitor of BCRP. Rosuvastatin, a BCRP substrate, is one of the most commonly prescribed medications in patients with h

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::9ccbdbcaab55c6640e6a082227a797fa
https://doi.org/10.1111/cts.13118

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Pharmacokinetic Drug‐Drug Interaction Study of Omecamtiv Mecarbil With Omeprazole, a Proton Pump Inhibitor, in Healthy Subjects

Autor: Sandeep Dutta, Bianca Terminello, Pegah Jafarinasabian, Winnie Sohn, Siddique Abbasi, Hanze Zhang, Edward Lee, Ashit Trivedi, Stephen Flach

Publikováno v: Clinical Pharmacology in Drug Development. 11:129-133

Omecamtiv mecarbil (OM) is a novel cardiac myosin activator in development for the treatment of heart failure (HF) with reduced ejection fraction. OM is administered as a 25-, 37.5-, or 50-mg modified-release formulation in patients with HF. Proton p

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::8e7002da55d84c07feb588158b398fe7
https://doi.org/10.1002/cpdd.997

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Phase 1, single-dose study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of etelcalcetide in pediatric patients with secondary hyperparathyroidism receiving hemodialysis

Autor: Claus Peter Schmitt, Winnie Sohn, Christina Taylan, Isidro B. Salusky, Jude Ngang, Lucy Yan, Bradley A. Warady, Mark A. Kroenke, Johan Vande Walle

Publikováno v: Pediatric Nephrology. 36:133-142

Data on the safety, efficacy of etelcalcetide in children with secondary hyperparathyroidism (sHPT) are limited.This phase 1 study (NCT02833857) evaluated the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) of single-dose etelcalce

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::b501a14bec6fc3585552ed3e27945314
https://doi.org/10.1007/s00467-020-04599-z

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Bridging adults and paediatrics with secondary hyperparathyroidism receiving haemodialysis: a pharmacokinetic‐pharmacodynamic analysis of cinacalcet

Autor: Adimoolam Narayanan, Per Olsson Gisleskog, Winnie Sohn, Ping Chen, Murad Melhem

Publikováno v: British Journal of Clinical Pharmacology

AIMS The aims of this study were to develop a pharmacokinetic (PK) and PK-pharmacodynamic (PK/PD) model of cinacalcet in adults and paediatrics with secondary hyperparathyroidism (SHPT) on dialysis, to test covariates of interest, and to perform simu

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::26643ea8ecf159ebc090a8a31c01864c
https://doi.org/10.1111/bcp.13900

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Pharmacokinetic Drug-Drug Interaction Study of Omecamtiv Mecarbil With Amiodarone and Digoxin in Healthy Subjects

Autor: Edward Lee, Sandeep Dutta, Winnie Sohn, Cheng-Pang Hsu, Stephen Flach, Pegah Jafarinasabian, Siddique Abbasi, Hanze Zhang, Shauna Hutton, Ashit Trivedi

Publikováno v: Clinical pharmacology in drug development. 11(3)

Omecamtiv mecarbil (OM), a novel cardiac myosin activator, is being evaluated for the treatment of heart failure with reduced ejection fraction. In vitro studies demonstrate OM as a substrate and inhibitor of P-glycoprotein (P-gp), which can result i

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::8c09162fe5b855e8b0ee0986e3cbfc09
https://pubmed.ncbi.nlm.nih.gov/34634185

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Abstract 13951: Safety, Tolerability and Efficacy of Single-dose Amg 890, a Novel Sirna Targeting Lp(a), in Healthy Subjects and Subjects With Elevated Lp(a)

Autor: Huei Wang, Gerald F. Watts, Helina Kassahun, Patrick M. Moriarty, Joel M. Neutel, Mary Elliott-Davey, Michael J. Koren, Jennifer Hellawell, Winnie Sohn, Howard Weintraub, Seth J. Baum, Tracy Varrieur, Martha Hernandez-Illas

Publikováno v: Circulation. 142

Introduction: Mendelian and epidemiological randomization studies have identified lipoprotein(a) [Lp(a)] as a risk factor for myocardial infarction and other atherosclerotic events. There are currently no approved medicines that selectively target Lp

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::9354408dada6e4a6ca2115ad8e4c16d7
https://doi.org/10.1161/circ.142.suppl_3.13951

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