Articles with "safety pharmacokinetics" as a keyword



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Safety, Pharmacokinetics, and Pharmacodynamics of the Oral TLR8 Agonist Selgantolimod in Chronic Hepatitis B

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Published in 2021 at "Hepatology"

DOI: 10.1002/hep.31795

Abstract: In patients with chronic hepatitis B (CHB) infection, activation of toll‐like receptor 8 may induce antiviral immunity and drive functional cure. Selgantolimod, a toll‐like receptor 8 agonist, was evaluated in patients with CHB who were… read more here.

Keywords: chronic hepatitis; hepatitis; agonist; pharmacokinetics pharmacodynamics ... See more keywords
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A Randomized Trial Assessing the Safety, Pharmacokinetics, and Efficacy During Morning Off of AZ‐009

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Published in 2022 at "Movement Disorders"

DOI: 10.1002/mds.28926

Abstract: Inhalation of apomorphine could be a faster‐acting and more user‐friendly alternative to subcutaneous injection for treating off periods in Parkinson's disease (PD). read more here.

Keywords: assessing safety; efficacy morning; trial assessing; randomized trial ... See more keywords
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Efficacy, safety, and pharmacokinetics of inhaled treprostinil in Japanese patients with pulmonary arterial hypertension

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Published in 2023 at "Pulmonary Circulation"

DOI: 10.1002/pul2.12198

Abstract: Abstract Treprostinil is a chemically stable analog of prostacyclin, and inhaled treprostinil was developed to deliver the effects directly to the pulmonary vasculature while minimizing systemic side effects. The objective of the study was to… read more here.

Keywords: efficacy; japanese patients; inhaled treprostinil; safety pharmacokinetics ... See more keywords
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A phase I dose-escalation study of the safety and pharmacokinetics of a tablet formulation of voxtalisib, a phosphoinositide 3-kinase inhibitor, in patients with solid tumors

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Published in 2017 at "Investigational New Drugs"

DOI: 10.1007/s10637-017-0467-7

Abstract: SummaryBackground Voxtalisib, a PI3K/mTOR inhibitor, has shown antitumor activity in capsule formulation in patients with solid tumors. This Phase I study assessed safety and pharmacokinetics of voxtalisib administered as immediate-release tablets in patients with solid… read more here.

Keywords: solid tumors; dose escalation; voxtalisib; safety pharmacokinetics ... See more keywords
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Safety and Pharmacokinetics of Intranasally Administered Heparin

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Published in 2022 at "Pharmaceutical Research"

DOI: 10.1007/s11095-022-03191-4

Abstract: Purpose Intranasally administered unfractionated heparin (UFH) and other sulfated polysaccharides are potential prophylactics for COVID-19. The purpose of this research was to measure the safety and pharmacokinetics of clearance of intranasally administered UFH solution from… read more here.

Keywords: safety pharmacokinetics; intranasally administered; nasal cavity; heparin ... See more keywords
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Safety, Pharmacokinetics and Pharmacodynamics of DS-1040, in Combination with Thrombectomy, in Japanese Patients with Acute Ischemic Stroke

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Published in 2022 at "Clinical Drug Investigation"

DOI: 10.1007/s40261-021-01112-8

Abstract: DS-1040 is a novel inhibitor of the activated form of thrombin-activatable fibrinolysis inhibitor that may have therapeutic potential in thromboembolic diseases, such as acute ischemic stroke (AIS) or pulmonary embolism. We undertook a Phase I… read more here.

Keywords: safety pharmacokinetics; acute ischemic; pharmacodynamics 1040; pharmacokinetics pharmacodynamics ... See more keywords
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Safety and Pharmacokinetics of Single and Multiple Ascending Doses of the Novel Oral Human GLP-1 Analogue, Oral Semaglutide, in Healthy Subjects and Subjects with Type 2 Diabetes

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Published in 2018 at "Clinical Pharmacokinetics"

DOI: 10.1007/s40262-018-0728-4

Abstract: BackgroundOral semaglutide is a novel tablet containing the human glucagon-like peptide-1 (GLP‑1) analogue semaglutide, co-formulated with the absorption enhancer sodium N-(8-[2-hydroxybenzoyl] amino) caprylate (SNAC). The safety and pharmacokinetics of oral semaglutide were investigated in two… read more here.

Keywords: glp analogue; safety pharmacokinetics; placebo; oral semaglutide ... See more keywords
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The Effect of Modafinil on the Safety and Pharmacokinetics of Lorlatinib: A Phase I Study in Healthy Participants

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Published in 2021 at "Clinical Pharmacokinetics"

DOI: 10.1007/s40262-021-01026-w

Abstract: Lorlatinib is a third-generation tyrosine kinase inhibitor approved for the second-line treatment of patients with advanced anaplastic lymphoma kinase-positive non-small cell lung cancer. Lorlatinib is metabolized by cytochrome P450 (CYP) 3A and contraindicated with strong… read more here.

Keywords: healthy participants; lorlatinib 100; study; modafinil safety ... See more keywords
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Safety and pharmacokinetics of Withaferin-A in advanced stage high grade osteosarcoma: A phase I trial

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Published in 2019 at "Journal of Ayurveda and Integrative Medicine"

DOI: 10.1016/j.jaim.2018.12.008

Abstract: Background Withaferin-A (WA), an active principle obtained from a traditional Indian herb known as Ashwagandha or the Indian ginseng, has been shown to prevent and cure urethane-induced lung tumors in mice, and also inhibit the… read more here.

Keywords: adverse events; high grade; safety; stage high ... See more keywords
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Phase I safety and pharmacokinetics study of rovalpituzumab tesirine in Japanese patients with advanced, recurrent small cell lung cancer.

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Published in 2019 at "Lung cancer"

DOI: 10.1016/j.lungcan.2019.07.025

Abstract: OBJECTIVES Rovalpituzumab tesirine (Rova-T™) is an antibody-drug conjugate that targets delta-like protein 3 (DLL3) on small cell lung cancer (SCLC) tumors, is internalized and releases the toxin pyrrolobenzodiazepine to induce cell death. This open label… read more here.

Keywords: safety pharmacokinetics; japanese patients; cell; lung cancer ... See more keywords
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Safety, pharmacokinetics and pharmacodynamics of a novel γ-aminobutyric acid (GABA) receptor potentiator, HSK3486, in Chinese patients with hepatic impairment

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Published in 2022 at "Annals of Medicine"

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