Mikael Sunnåker
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View article: A Phase 2a Trial of Myeloperoxidase Inhibitor Mitiperstat in Non‐Cirrhotic Metabolic Dysfunction‐Associated Steatohepatitis
A Phase 2a Trial of Myeloperoxidase Inhibitor Mitiperstat in Non‐Cirrhotic Metabolic Dysfunction‐Associated Steatohepatitis Open
Background and Aims Neutrophil myeloperoxidase is involved in different inflammatory diseases, including metabolic dysfunction‐associated steatohepatitis (MASH). Mitiperstat is a highly potent myeloperoxidase inhibitor. This phase 2a clini…
View article: No Evidence of <scp>QTc</scp> Interval Prolongation With Baxdrostat Treatment: Concentration–QTc Modeling Assessment
No Evidence of <span>QTc</span> Interval Prolongation With Baxdrostat Treatment: Concentration–QTc Modeling Assessment Open
Baxdrostat is a novel, highly potent, selective, competitive inhibitor of human aldosterone synthase currently under development for the treatment of uncontrolled and resistant hypertension and chronic kidney disease. We assessed the risk …
View article: Population Pharmacokinetics of Osimertinib in Patients With Non‐Small Cell Lung Cancer
Population Pharmacokinetics of Osimertinib in Patients With Non‐Small Cell Lung Cancer Open
Population pharmacokinetics (popPK) modeling for osimertinib, a third‐generation, irreversible, oral epidermal growth factor receptor (EGFR)‐tyrosine kinase inhibitor (TKI) that potently and selectively inhibits both EGFR‐TKI sensitizing m…
View article: Exposure–response modelling of osimertinib in patients with non‐small cell lung cancer
Exposure–response modelling of osimertinib in patients with non‐small cell lung cancer Open
Aims Osimertinib is a third‐generation, irreversible, central nervous system‐active, epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) with efficacy in EGFR‐mutated non‐small cell lung cancer (NSCLC). We assessed the …
View article: The effect of severe renal impairment on the pharmacokinetics, safety and tolerability of mitiperstat
The effect of severe renal impairment on the pharmacokinetics, safety and tolerability of mitiperstat Open
Aims Mitiperstat is a novel, highly potent myeloperoxidase inhibitor being evaluated in patients with cardio‐metabolic disease (phase 2). These patients often have impaired renal function, which may affect mitiperstat pharmacokinetics. Thi…
View article: From Plan to Pivot: How Model‐Informed Drug Development Shaped the Dose Strategy of the Zibotentan/Dapagliflozin <i>ZENITH</i> Trials
From Plan to Pivot: How Model‐Informed Drug Development Shaped the Dose Strategy of the Zibotentan/Dapagliflozin <i>ZENITH</i> Trials Open
Getting the dose right is a key challenge in drug development; model‐informed drug development (MIDD) provides powerful tools to shape dose strategies and inform decision making. In this tutorial, the case study of the ZENITH trials showca…
View article: #362 Dosing low, winning high: unlocking the promise of endothelin antagonism for the treatment of CKD in the zibotentan/dapagliflozin ZENITH trials
#362 Dosing low, winning high: unlocking the promise of endothelin antagonism for the treatment of CKD in the zibotentan/dapagliflozin ZENITH trials Open
Background and Aims The Phase 2b ZENITH-CKD trial demonstrated that combined treatment with the endothelin A receptor (ETAR) antagonist zibotentan and the sodium-glucose co-transporter-2 inhibitor (SGLT2i) dapagliflozin yields a robust and…
View article: The myeloperoxidase inhibitor mitiperstat (<scp>AZD4831</scp>) does not prolong the <scp>QT</scp> interval at expected therapeutic doses
The myeloperoxidase inhibitor mitiperstat (<span>AZD4831</span>) does not prolong the <span>QT</span> interval at expected therapeutic doses Open
Mitiperstat is a myeloperoxidase inhibitor in clinical development for treatment of patients with heart failure and preserved or mildly reduced ejection fraction, non‐alcoholic steatohepatits and chronic obstructive pulmonary disease. We a…
View article: Pharmacokinetics and Tolerability of Zibotentan in Patients with Concurrent Moderate Renal and Moderate Hepatic Impairment
Pharmacokinetics and Tolerability of Zibotentan in Patients with Concurrent Moderate Renal and Moderate Hepatic Impairment Open
ClinicalTrials.gov identifier: NCT05112419.
View article: Efficacy and safety of zibotentan and dapagliflozin in patients with chronic kidney disease: study design and baseline characteristics of the ZENITH-CKD trial
Efficacy and safety of zibotentan and dapagliflozin in patients with chronic kidney disease: study design and baseline characteristics of the ZENITH-CKD trial Open
Background Sodium–glucose co-transporter 2 inhibitors (SGLT2is) are part of the standard of care for patients with chronic kidney disease (CKD), both with and without type 2 diabetes. Endothelin A (ETA) receptor antagonists have also been …
View article: TopoFilter: a MATLAB package for mechanistic model identification in systems biology
TopoFilter: a MATLAB package for mechanistic model identification in systems biology Open
Data underlying the figures in the publication “TopoFilter: a MATLAB package for mechanistic model identification in systems biology” published in BMC Bioinformatics, 2020, 21, 34. The .zip folder with the datasets generated and/or analyze…
View article: TopoFilter: a MATLAB package for mechanistic model identification in systems biology
TopoFilter: a MATLAB package for mechanistic model identification in systems biology Open
Data underlying the figures in the publication “TopoFilter: a MATLAB package for mechanistic model identification in systems biology” published in BMC Bioinformatics, 2020, 21, 34. The .zip folder with the datasets generated and/or analyze…
View article: Design and rationale of the Management of High Bleeding Risk Patients Post Bioresorbable Polymer Coated Stent Implantation With an Abbreviated Versus Standard DAPT Regimen (MASTER DAPT) Study
Design and rationale of the Management of High Bleeding Risk Patients Post Bioresorbable Polymer Coated Stent Implantation With an Abbreviated Versus Standard DAPT Regimen (MASTER DAPT) Study Open
The MASTER DAPT study is the first randomized controlled trial aiming at ascertaining the optimal duration of antiplatelet therapy in HBR patients treated with sirolimus-eluting bioresorbable polymer-coated stent implantation.