Effects of Hepatic Impairment on the Pharmacokinetic Profile and Safety of Lobeglitazone
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DOI: 10.1002/cpdd.1045
Abstract: In this open‐label, single‐dose, parallel‐group study, we compared the pharmacokinetic profile and safety of lobeglitazone, a thiazolidinedione acting as an agonist for peroxisome proliferator‐activated receptors, in patients with hepatic impairment (HI) and healthy matched controls… read more here.
Keywords: profile safety; safety lobeglitazone; lobeglitazone; pharmacokinetic profile ... See more keywords
Rimegepant 75 mg in Subjects With Hepatic Impairment: Results of a Phase 1, Open-Label, Single-Dose, Parallel-Group Study.
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DOI: 10.1002/cpdd.1244
Abstract: Rimegepant is a small-molecule calcitonin gene-related peptide receptor antagonist (gepant) with demonstrated efficacy and safety in the acute and preventive treatment of migraine. Here, we report the pharmacokinetics and safety of a single 75-mg oral… read more here.
Keywords: label single; rimegepant subjects; hepatic impairment; impairment ... See more keywords
A Phase 1 Study to Evaluate the Pharmacokinetics and Safety of Cabotegravir in Patients With Hepatic Impairment and Healthy Matched Controls
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DOI: 10.1002/cpdd.655
Abstract: Cabotegravir is an investigational integrase inhibitor in development for the treatment and pre‐exposure prophylaxis of HIV‐1 infection. Liver disease is a major cause of morbidity and mortality in HIV‐infected individuals and can impact the pharmacokinetics… read more here.
Keywords: cabotegravir; phase study; impairment healthy; hepatic impairment ... See more keywords
Effect of Renal or Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of Intravenous Rivipansel
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DOI: 10.1002/cpdd.842
Abstract: Two studies evaluated the effects of renal and hepatic impairment on pharmacokinetics and safety of rivipansel (NCT02813798, NCT02871570). A single intravenous 840‐mg rivipansel dose was administered to subjects with renal impairment or normal renal function… read more here.
Keywords: rivipansel; renal hepatic; hepatic impairment; impairment pharmacokinetics ... See more keywords
Effect of Hepatic Impairment on Cobimetinib Pharmacokinetics: The Complex Interplay Between Physiological Changes and Drug Characteristics
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DOI: 10.1002/cpdd.847
Abstract: Cobimetinib is a kinase inhibitor indicated for use in combination with vemurafenib for treatment of unresectable/metastatic melanoma with specific BRAF mutations. Cobimetinib is extensively metabolized in liver; thus, patients with hepatic impairment (HI) might have… read more here.
Keywords: normal hepatic; hepatic impairment; hepatic function; drug ... See more keywords
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
The Effect of Hepatic Impairment on the Pharmacokinetics of Intravenously Administered Felcisetrag (TAK‐954)
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DOI: 10.1002/jcph.2044
Abstract: Felcisetrag (formerly known as TAK‐954) is a selective serotonin receptor agonist under investigation for use in patients with postoperative gastrointestinal dysfunction. The safety, tolerability, and pharmacokinetics (PK) of intravenous (i.v.) felcisetrag have been studied, but… read more here.
Keywords: effect hepatic; hepatic impairment; time; felcisetrag ... 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
Dotinurad: a clinical pharmacokinetic study of a novel, selective urate reabsorption inhibitor in subjects with hepatic impairment
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DOI: 10.1007/s10157-019-01816-4
Abstract: Background Dotinurad is a novel, selective urate reabsorption inhibitor, which reduces serum uric acid levels by inhibiting the urate transporter 1 (URAT1). We compared the pharmacokinetics (PK), pharmacodynamics (PD), and safety of dotinurad in subjects… read more here.
Keywords: hepatic impairment; group; study; novel selective ... 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