Effect of Varying Degrees of Hepatic Impairment on the Pharmacokinetics of Omecamtiv Mecarbil.
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DOI: 10.1002/cpdd.969
Abstract: Omecamtiv mecarbil (OM) is a novel selective cardiac myosin activator under investigation for the treatment of heart failure with reduced ejection fraction. OM is primarily eliminated via metabolism mediated by multiple cytochrome P450 enzymes. This… read more here.
Keywords: omecamtiv mecarbil; hepatic impairment; moderate hepatic; impairment ... See more keywords
Characterization of the Effect of Hepatic Impairment on Upadacitinib Pharmacokinetics
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DOI: 10.1002/jcph.1414
Abstract: Upadacitinib is a selective Janus kinase 1 inhibitor being developed for the treatment of several inflammatory autoimmune diseases, including rheumatoid arthritis. Upadacitinib is a nonsensitive substrate for metabolism by cytochrome P450 3A enzymes. This open‐label,… read more here.
Keywords: hepatic impairment; upadacitinib pharmacokinetics; effect; moderate hepatic ... See more keywords
Maribavir Pharmacokinetics and Safety in Participants With Moderate Hepatic Impairment: A Phase 1, Open‐Label, Single‐Dose, Parallel Group Study
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DOI: 10.1002/jcph.2155
Abstract: Maribavir, an orally bioavailable antiviral, has shown superior activity against posttransplant cytomegalovirus infection compared with conventional antivirals. It is primarily metabolized in the liver. This open‐label, single‐center study evaluated the effect of hepatic impairment on… read more here.
Keywords: participants moderate; hepatic impairment; maribavir; impairment ... See more keywords
Pharmacokinetics and Safety of Single-Dose Esaxerenone in Japanese Subjects with Mild to Moderate Hepatic Impairment
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DOI: 10.1007/s12325-019-01121-2
Abstract: Introduction The mineralocorticoid receptor (MR) blocker esaxerenone is a new treatment for hypertension in Japan and under development for treatment of diabetic nephropathy. Hepatic impairment is known to impact the pharmacokinetics (PKs) of other MR… read more here.
Keywords: normal hepatic; hepatic impairment; moderate hepatic; impairment ... See more keywords
Single-Dose Pharmacokinetics of Milvexian in Participants with Mild or Moderate Hepatic Impairment Compared with Healthy Participants
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DOI: 10.1007/s40262-022-01110-9
Abstract: Patients with hepatic impairment receiving antithrombotic agents metabolized primarily through the liver can be at risk for bleeding. Milvexian (BMS-986177/JNJ-70033093) is a small-molecule, active-site inhibitor of activated Factor XI (FXIa). Modulation of FXI may provide… read more here.
Keywords: moderate hepatic; impairment; hepatic function; mild moderate ... See more keywords
Effects of Child-Pugh B Cirrhosis on Pharmacokinetics of Tofogliflozin, a New Sodium-Glucose Co-Transporter (SGLT2) Inhibitor.
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DOI: 10.1055/a-1202-0818
Abstract: BACKGROUND Tofogliflozin is a highly selective sodium-glucose co-transporter 2 (SGLT2) inhibitor. A mass balance study with combinations of microdoses revealed that tofogliflozin has high oral bioavailability (97.5%) and that tofogliflozin in circulation is eliminated primarily… read more here.
Keywords: sodium glucose; tofogliflozin; glucose transporter; hepatic impairment ... See more keywords
Safety, pharmacokinetics and pharmacodynamics of a novel γ-aminobutyric acid (GABA) receptor potentiator, HSK3486, in Chinese patients with hepatic impairment
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DOI: 10.1080/07853890.2022.2129433
Abstract: Abstract Background The primary objective of this study was to investigate if hepatic impairment alters the safety, pharmacokinetics, and pharmacodynamics of HSK3486. Research design and methods This was a clinical trial of HSK3486 in subjects… read more here.
Keywords: hsk3486; mild moderate; hepatic impairment; safety pharmacokinetics ... See more keywords
Pharmacokinetics and safety of sacubitril/valsartan (LCZ696) in patients with mild and moderate hepatic impairment .
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DOI: 10.5414/cp202988
Abstract: OBJECTIVES To assess the protein binding and pharmacokinetics of sacubitril/valsartan analytes (sacubitril, sacubitrilat, and valsartan) in an open-label, single oral dose (200 mg), parallel-group study in patients with mild and moderate hepatic impairment (Child-Pugh class A… read more here.
Keywords: sacubitril valsartan; hepatic impairment; moderate hepatic; impairment ... See more keywords