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PubMed Journals Articles About "A Study To Determine The Relative Bioavailability Of The MEK Inhibitor, Trametinib, In Subjects With Solid Tumor Malignancies" RSS

02:06 EDT 20th October 2018 | BioPortfolio

A Study To Determine The Relative Bioavailability Of The MEK Inhibitor, Trametinib, In Subjects With Solid Tumor Malignancies PubMed articles on BioPortfolio. Our PubMed references draw on over 21 million records from the medical literature. Here you can see the latest A Study To Determine The Relative Bioavailability Of The MEK Inhibitor, Trametinib, In Subjects With Solid Tumor Malignancies articles that have been published worldwide.

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Showing "Study Determine Relative Bioavailability Inhibitor Trametinib Subjects With" PubMed Articles 1–25 of 72,000+

Bioequivalence of Canakinumab Injected Subcutaneously via an Autoinjector Device or a Prefilled Safety Syringe Device in Healthy Subjects.

Canakinumab, a high-affinity human anti-interleukin-1β monoclonal antibody, is being used for the treatment of a broad spectrum of inflammatory diseases. This phase 1 study compared the relative bioavailability of a single dose of subcutaneous canakinumab either self-administered with an autoinjector (AI) or administered by a health care professional (HCP) with a prefilled safety syringe (SS) in healthy subjects. The study enrolled 80 subjects randomized 1:1 to receive 150 mg/mL of a liquid formulation of...


Evaluation of a Janus Kinase 1 inhibitor, PF-04965842, in healthy subjects: a phase 1, randomized, placebo-controlled, dose-escalation study.

To determine the safety, tolerability, pharmacokinetics and pharmacodynamics of the Janus Kinase (JAK) 1-selective inhibitor, PF-04965842.

The clinically approved MEK inhibitor Trametinib efficiently blocks influenza A virus propagation and cytokine expression.

Influenza A virus (IAV) infections are still a major global threat for humans, especially for the risk groups of young children and the elderly. Annual epidemics and sporadically occurring pandemics highlight the necessity of effective antivirals that can limit viral replication. The currently licensed antiviral drugs target viral factors and are prone to provoke viral resistance. In infected host cells IAV induces various cellular signaling cascades. The Raf/MEK/ERK signaling cascade is indispensable for I...


Relative Bioavailability Risk Assessment: A Systematic Approach to Assessing In Vivo Risk Associated with CM&C related Changes.

Relative bioavailability (RBA) studies are often carried out to bridge changes made between drug products used for clinical studies. In this work we describe the development of a risk assessment tool that comprehensively and objectively assesses the risk of non-comparable in vivo performance associated with CM&C-related changes. The risk assessment tool is based on a risk grid that provides a quantitative context to facilitate discussions to determine the need for an in vivo RBA study. Relevant regulatory g...

Bioavailability of coenzyme Q10 supplements depends on carrier lipids and solubilization.

Bioavailability of supplements with coenzyme Q10 (CoQ) in humans seems to depend on the excipients of formulations and on physiological characteristics of the individuals. The aim of this study was to determine which factors presented in CoQ supplements affect the different response to CoQ in humans.

Relationship between relative skeletal muscle mass and non-alcoholic fatty liver disease: A 7-year longitudinal study.

Non-alcoholic fatty liver disease (NAFLD) has been associated with relative skeletal muscle mass in several cross-sectional studies. We explored the impacts of relative skeletal muscle mass and changes in relative muscle mass over time on the development of incident NAFLD or the resolution of baseline NAFLD in a large, longitudinal, population-based 7-year cohort study. We included 12,624 subjects without baseline NAFLD and 2,943 subjects with baseline NAFLD who underwent health check-up examinations. A tot...

Effect of Fluconazole Coadministration and CYP2C9 Genetic Polymorphism on Siponimod Pharmacokinetics in Healthy Subjects.

The aim of this study was to assess the pharmacokinetics (PK) and safety/tolerability of siponimod in healthy subjects when coadministered with (1) the moderate cytochrome P450 (CYP) 2C9 and CYP3A inhibitor fluconazole (Study A), and (2) with three different CYP2C9 genotype variants (Study B).

First-in-Human Studies for a Selective RET Tyrosine Kinase Inhibitor, GSK3179106, to Investigate the Safety, Tolerability, and Pharmacokinetics in Healthy Volunteers.

Rearranged during transfection (RET), a neuronal growth factor receptor tyrosine kinase, regulates the development of the sympathetic, parasympathetic, motor, and sensory neurons in the enteric nervous system. GSK3179106 is a RET kinase inhibitor that was administered in double-blind, randomized, placebo-controlled single-dose and repeat-dose studies in healthy subjects to investigate its pharmacokinetics and safety/tolerability. In the single-dose study (n = 16), GSK3179106 was dosed from 10 mg to 800 mg, ...

Association of Oxytocin with Glucose Intolerance and Inflammation Biomarkers in Metabolic Syndrome Patients with and without Prediabetes.

The aim of this study was to explore the differences in OXT levels in metabolic syndrome (MetS) subjects, newly diagnosed type 2 diabetes mellitus (T2D), and prediabetes subjects vs. MetS subjects without glucose intolerance (non-diabetic MetS). It was also intended to determine the relationship between plasma OXT levels and inflammatory markers in those subjects.

Relative and Absolute Bioavailability Study of Emicizumab to Bridge Drug Products and Subcutaneous Injection Sites in Healthy Volunteers.

Emicizumab (ACE910) is a bispecific antibody that is a novel, subcutaneously injectable treatment for patients with hemophilia A. This study assessed the relative bioavailability of emicizumab between old and new drug products (DPs) and among 3 commonly used subcutaneous injection sites (abdomen, upper arm, and thigh), together with its absolute bioavailability in healthy volunteers. Forty-eight healthy volunteers were randomized into 4 groups to receive a single subcutaneous injection of 1 mg/kg with the o...

Pharmacokinetic, bioavailability and tissue distribution study of MP3950, a new gastroprokinetic candidate compound, in rat using UPLC-MS/MS.

MP3950 is being developed as a gastroprokinetic candidate compound. To illustrate the pharmacokinetic profiles, absolute bioavailability after intravenous administration and oral administration with MP3950 as well as tissue distribution in vivo, an UPLC-MS/MS approach which was rapid and selective was developed to determine MP3950 in plasma and tissue of rat. Sample pre-treatment of plasma sample was one-step protein precipitation. 0.1% formic acid containing 5 mmol/L ammonium acetate-methanol(55/45,v/v) ...

Impact of sludge conditioning treatment on the bioavailability of pyrene in sewage sludge.

Conditioning is an indispensable step to improve mechanical dewatering of municipal sewage sludge. However, it is still unclear how sludge conditioning treatments impact the bioavailability of polycyclic aromatic hydrocarbons (PAHs) in sewage sludge that potentially influences the biodegradation of PAHs during the composting of dewatered sludge cake. In the present study, five sludge conditioning treatments, including chemical acidification, bioleaching driven by Acidithiobacillus ferrooxidans, chemical con...

Pharmacokinetics and Safety After a Single Dose of Imarikiren in Subjects with Renal or Hepatic Impairment.

Imarikiren hydrochloride (TAK-272; SCO-272) is a novel direct renin inhibitor. The objective of this study was to determine the effects of renal impairment (RI) or hepatic impairment (HI) on the pharmacokinetics and safety of imarikiren.

Non-alcoholic fatty liver disease is a strong predictor of coronary artery calcification in metabolically healthy subjects: A cross-sectional, population-based study in middle-aged subjects.

This study aims to estimate the relationship between non-alcoholic fatty liver disease (NAFLD) and measures of atherosclerotic cardiovascular disease (ASCVD), and to determine to what extent such relationships are modified by metabolic risk factors.

Rosuvastatin calcium nanoparticles: Improving bioavailability by formulation and stabilization codesign.

Rosuvastatin calcium (ROSCa) is a poorly soluble drug with bioavailability not exceeding 20%. Decreasing the particle size may enhance its solubility, dissolution rate and bioavailability. Therefore, the aim of the current study is to prepare ROSCa nanoparticles by wet milling technique using planetary ball mill. The codesign between formulation and stabilization of nanoparticles was studied to achieve both high dissolution as well as bioavailability.

Pharmacokinetics and Comparative Bioavailability of a Levothyroxine Sodium Oral Solution and Soft Capsule.

A new formulation of levothyroxine sodium has been developed in the form of an oral solution contained in unit-dose ampules. A study has been conducted to compare the bioavailability of levothyroxine sodium oral solution and levothyroxine sodium soft capsule in healthy volunteers under fasting conditions. The rate and extent of absorption of the new levothyroxine solution were also evaluated when administered on dilution in water or directly into the mouth without water. In each period, according to the ran...

Thermo-sensitive gel in glaucoma therapy for enhanced bioavailability: In vitro characterization, in vivo pharmacokinetics and pharmacodynamics study.

Glaucoma is a chronic ophthalmic disease, which has become one of the leading causes to progressive and irreversible blindness. Current ophthalmic drug delivery to treat glaucoma is mostly eyedrop, whose rapid elimination on corneal surface can lead to poor bioavailability. The present study was aimed to develop a timolol maleate loaded thermo-sensitive gel (TM-TSG) with improved bioavailability to treat glaucoma.

Relative Bioavailability of Iron in Bangladeshi Traditional Meals Prepared with Iron-Fortified Lentil Dal.

Due to low Fe bioavailability and low consumption per meal, lentil must be fortified to contribute significant bioavailable Fe in the Bangladeshi diet. Moreover, since red lentil is dehulled prior to consumption, an opportunity exists at this point to fortify lentil with Fe. Thus, in the present study, lentil was Fe-fortified (using a fortificant Fe concentration of 2800 µg g) and used in 30 traditional Bangladeshi meals with broad differences in concentrations of iron, phytic acid (PA), and relative Fe bi...

Response to BRAF/MEK Inhibition After Progression With BRAF Inhibition in a Patient With Anaplastic Pleomorphic Xanthoastrocytoma.

Pleomorphic xanthoastrocytoma (PXA) is a rare primary central nervous system tumor which frequently harbors mutations in BRAF. Anaplastic PXA follow a more aggressive course than their nonanaplastic counterparts. We present the case of an anaplastic PXA initially treated with the BRAF inhibitor vemurafenib. After progression of disease the MEK inhibitor trametinib was added to the regimen leading to radiographic improvement. The rationale for combined BRAF and MEK inhibition in PXA is reviewed.

Therapeutic effects of targeting RAS-ERK signaling in giant congenital melanocytic nevi.

Most giant congenital melanocytic nevi (GCMN) exhibit an activating mutation in NRAS. Constitutive activation of the RAS-ERK signaling pathway induces proliferation in nevus cells and plays a pivotal role in melanoma development. In this study, we studied the efficacy of RAS-ERK pathway targeted therapy in GCMN. We isolated nevus cells from GCMN (GNCs) and compared the morphology of GNCs with normal melanocytes and the A375 melanoma cell line. Proliferation curves of GNCs and A375 cells were determined usin...

Proton Pump Inhibitor Use, H-Receptor Antagonist Use, and Risk of Incident Clinical Vertebral Fracture in Women.

The few prospective studies examining the relation between proton pump inhibitor (PPI) use and risk of vertebral fracture (VF) suggest a higher risk, but the magnitude of the association has been inconsistent. Moreover, no prospective studies have examined the association between substantially longer duration of PPI use and VF risk. Our objective was to determine the association between PPI use, HRA use, and incident clinical VF in women. We conducted a prospective study in 55,545 women participating in the...

Safety, Tolerability, and Pharmacokinetics of Single and Repeat Doses of Nemiralisib Administered via the Ellipta Dry Powder Inhaler to Healthy Subjects.

Novel therapies to treat chronic obstructive pulmonary disease are highly desirable. The safety, tolerability, and pharmacokinetic (PK) parameters of nemiralisib, a phosphoinositide 3-kinase δ inhibitor, administered via the Ellipta dry powder inhaler (GlaxoSmithKline, Research Triangle Park, North Carolina) was evaluated, including an assessment of oral bioavailability.

Dickkopf-1 (Dkk-1) serum levels in systemic sclerosis and rheumatoid arthritis patients: correlation with the Trabecular Bone Score (TBS).

The aim of this research was to determine any correlations between Dickkopf-1 serum levels (Dkk-1, a natural inhibitor of the Wnt signaling pathway promoting osteoclastogenesis) and the Trabecular Bone Score (TBS), in systemic sclerosis (SSc) and rheumatoid arthritis (RA) patients. It also aimed at determining any difference in Dkk-1 serum levels between SSc and RA patients and a control group (CNT) of healthy subjects. A prospective study was carried out in 60 SSc and 60 RA patients and 60 CNT. Dkk-1 serum...

Effect of a spacer on total systemic and lung bioavailability in healthy volunteers and in vitro performance of the Symbicort (budesonide/formoterol) pressurized metered dose inhaler.

Many patients with chronic obstructive pulmonary disease or asthma experience difficulties in coordinating inhalation with pressurized metered-dose inhaler (pMDI) actuation. The use of a spacer device can improve drug delivery in these patients. The aim of this study was to establish the relative bioavailability of single doses of Symbicort (budesonide/formoterol) pMDI 160/4.5 μg/actuation (2 actuations) used with and without a spacer device. In addition, an in vitro study was conducted to characterize per...

High imminent vertebral fracture risk in subjects with COPD with a prevalent or incident vertebral fracture.

Subjects with chronic obstructive pulmonary disease (COPD) have an increased risk of vertebral fractures (VFs), however VF incidence is largely unknown. Therefore the aim of our study was to determine the incidence of new and/or worsening VFs in subjects with COPD. Smokers and subjects with COPD (GOLD II-IV) from the ECLIPSE study with complete set of chest CT scans (baseline, one and three years follow-up) to evaluate vertebrae T1 down to L1 were included. If a VF was diagnosed on the last scan, detailed V...


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