Výsledky vyhledávání - "Jennifer, Hellawell"

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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Evaluation of the Pharmacokinetics and Safety of AMG 986 Tablet and Capsule Formulations in Healthy Adult Subjects: A Phase I, Open-Label, Randomized Study

Autor: Ashit Trivedi, Y.-H. Kiang, Robert E. Saw, Guilong Charles Cheng, Omar Mather, Silvia Vega, Jennifer Hellawell, Edward Lee

Publikováno v: Drugs in R&D. 22:147-154

AMG 986 is a first-in-class, novel apelin receptor small molecule agonist initially developed for the treatment of heart failure. The current phase I study was conducted to evaluate the pharmacokinetics and safety of a single-dose 200-mg capsule form

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::827248f640ce448856b24b1346f53a1c
https://doi.org/10.1007/s40268-022-00388-1

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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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Stabilization of Cardiac Function With Diflunisal in Transthyretin (ATTR) Cardiac Amyloidosis

Autor: John L. Berk, Graham Lohrmann, Omar K. Siddiqi, Deepa M. Gopal, Jennifer Hellawell, Mathew S. Maurer, Lawreen H. Connors, Roberta Mussinelli, Nirupama Vellanki, Alexandra Pipilas, Jonathan C. Fox, Frederick L. Ruberg

Publikováno v: Journal of Cardiac Failure. 26:753-759

Background Transthyretin amyloidosis cardiomyopathy (ATTR-CM) is an underappreciated cause of heart failure that results from misfolded TTR (prealbumin) protein. Diflunisal is an approved non-steroidal anti-inflammatory drug that stabilizes TTR, with

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::b53563de8346c4a26677c412140ebf48
https://doi.org/10.1016/j.cardfail.2019.11.024

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A First-in-Human Study of AMG 986, a Novel Apelin Receptor Agonist, in Healthy Subjects and Heart Failure Patients

Autor: Peter Winkle, Steven Goldsmith, Michael J. Koren, Serge Lepage, Jennifer Hellawell, Ashit Trivedi, Kate Tsirtsonis, Siddique A. Abbasi, Allegra Kaufman, Richard Troughton, Adriaan Voors, Jean-Sebastien Hulot, Erwan Donal, Navid Kazemi, Joel Neutel

Publikováno v: Cardiovascular Drugs and Therapy
Cardiovascular Drugs and Therapy, Springer Verlag, 2022, ⟨10.1007/s10557-022-07328-w⟩
Cardiovascular Drugs and Therapy, 2022, ⟨10.1007/s10557-022-07328-w⟩

International audience; Purpose: AMG 986 is a novel apelin receptor (APJ) agonist that improves cardiac contractility in animal models without adversely impacting hemodynamics. This phase 1b study evaluated the safety/tolerability, pharmacokinetics,

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::92c1496524080225692356d28a4478ac
https://hal.archives-ouvertes.fr/hal-03656861

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A Phase I, Open-label, Single-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of AMG 986 in Healthy Japanese Subjects

Autor: Ashit Trivedi, Omar Mather, Silvia Vega, Shauna Hutton, Jennifer Hellawell, Edward Lee

Publikováno v: Drugs in RD. 22(2)

AMG 986 is a first-in-class, novel apelin receptor small molecule agonist initially developed as a treatment for patients with heart failure (HF). Previously, a first-in-human study of AMG 986 was conducted in healthy and HF subjects; however, AMG 98

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::afbcaf12bd69db6187dddc9f660afca7
https://pubmed.ncbi.nlm.nih.gov/35279815

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Effect of Severe Renal Impairment on the Safety, Tolerability, and Pharmacokinetics of AMG 986

Autor: Ashit, Trivedi, Omar, Mather, Silvia, Vega, Mary Ann, Simiens, Jennifer, Hellawell, Edward, Lee

Publikováno v: Drugs in RD. 22(1)

AMG 986 is a first-in-class, novel apelin receptor small molecule agonist initially developed for the treatment of heart failure (HF). The safety and pharmacokinetics (PK) of AMG 986 in participants with renal impairment (RI) remains unknown.This pha

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=pmid________::f05c17480e4878d073601bea4cf1aefe
https://pubmed.ncbi.nlm.nih.gov/35092583

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A Phase 1, Open-Label Study to Evaluate the Effect of Food and Concomitant Itraconazole Administration on the Pharmacokinetics of AMG 986 in Healthy Subjects

Autor: Ashit Trivedi, Omar Mather, Silvia Vega, Shauna Hutton, Jennifer Hellawell, Edward Lee

Publikováno v: Clinical pharmacology in drug developmentReferences. 11(7)

This phase 1, open-label study evaluated the effect of food and administration of the cytochrome P450 3A4 and P-glycoprotein inhibitor itraconazole (ITZ) on the pharmacokinetics of AMG 986. In cohort 1, 12 healthy subjects received a single oral dose

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::8fd8950f9fef144cf6a6cf85e830d2e0
https://pubmed.ncbi.nlm.nih.gov/35247290

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