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1

Physiologically-Based Pharmacokinetic Modeling of Macitentan: Prediction of Drug–Drug Interactions

de Kanter, Ruben, Sidharta, Patricia N., Delahaye, Stéphane, Gnerre, Carmela, Segrestaa, Jerome, Buchmann, Stephan, Kohl, Christopher, Treiber, Alexander

Journal:

Clinical Pharmacokinetics

Year:

2016

Language:

english

File:

PDF, 858 KB

english, 2016

2

Bioequivalence of Macitentan and Tadalafil Given as Fixedâdose Combination or Singleâcomponent Tablets in Healthy Subjects

Grill, Simon, Bruderer, Shirin, Sidharta, Patricia N., Antonova, Mariya, Globig, Susanne, Carlson, James, Schultz, Armin, Csonka, DÃ©nes

Journal:

British Journal of Clinical Pharmacology

Year:

2020

File:

PDF, 838 KB

2020

3

Single-Dose Pharmacokinetics and Tolerability of Aprocitentan, a Dual Endothelin Receptor Antagonist, in Subjects with Severe Renal Function Impairment

Sidharta, Patricia N., Ulč, Ivan, Dingemanse, Jasper

Journal:

Clinical Drug Investigation

Year:

2019

Language:

english

File:

PDF, 717 KB

english, 2019

4

Absorption, distribution, metabolism, and excretion of macitentan, a dual endothelin receptor antagonist, in humans

Bruderer, Shirin, Hopfgartner, Gérard, Seiberling, Michael, Wank, Janine, Sidharta, Patricia N., Treiber, Alexander, Dingemanse, Jasper

Journal:

Year:

2012

Language:

english

File:

PDF, 1.26 MB

english, 2012

5

The effect of the glucosylceramide synthase inhibitor lucerastat on cardiac repolarization: results from a thorough QT study in healthy subjects

Mueller, Markus S., Sidharta, Patricia N., Voors-Pette, Christine, Darpo, Borje, Xue, Hongqi, Dingemanse, Jasper

Journal:

Orphanet Journal of Rare Diseases

Year:

2020

File:

PDF, 1.34 MB

2020

6

Pharmacokinetic interactions between simvastatin and setipiprant, a CRTH2 antagonist

Gehin, Martine, Sidharta, Patricia N., Gnerre, Carmela, Treiber, Alexander, Halabi, Atef, Dingemanse, Jasper

Journal:

European Journal of Clinical Pharmacology

Year:

2015

Language:

english

File:

PDF, 591 KB

english, 2015

7

Investigation of the Effect of Macitentan on the Pharmacokinetics and Pharmacodynamics of Warfarin in Healthy Male Subjects

Sidharta, Patricia N., Dietrich, Hartmut, Dingemanse, Jasper

Journal:

Clinical Drug Investigation

Year:

2014

Language:

english

File:

PDF, 423 KB

english, 2014

8

Single- and multiple-dose tolerability and pharmacokinetics of the CRTH2 antagonist setipiprant in healthy male subjects

Sidharta, Patricia N., Diamant, Zuzana, Dingemanse, Jasper

Journal:

Fundamental & Clinical Pharmacology

Year:

2014

Language:

english

File:

PDF, 226 KB

english, 2014

9

Assessment of peripheral serotonin synthesis using stable isotope-labeled tryptophan

Gehin, Martine, Welford, Richard W. D., Garzotti, Marco, Vercauteren, Magali, Groenen, Peter M.A., Nayler, Oliver, Sidharta, Patricia N., Dingemanse, Jasper

Journal:

Clinical Pharmacology & Therapeutics

Year:

2018

Language:

english

File:

PDF, 2.25 MB

english, 2018

10

Efficacy, safety and clinical pharmacology of macitentan in comparison to other endothelin receptor antagonists in the treatment of pulmonary arterial hypertension

Dingemanse, Jasper, Sidharta, Patricia N, Maddrey, Willis C, Rubin, Lewis J, Mickail, Hani

Journal:

Expert Opinion on Drug Safety

Year:

2014

Language:

english

File:

PDF, 546 KB

english, 2014

11

Macitentan, a dual endothelin receptor antagonist for the treatment of pulmonary arterial hypertension, does not affect cardiac repolarization in healthy subjects

Lindegger, Nicolas, Sidharta, Patricia N., Reseski, Kathrin, Dingemanse, Jasper

Journal:

Pulmonary Pharmacology & Therapeutics

Year:

2014

Language:

english

File:

PDF, 874 KB

english, 2014

12

Pharmacokinetics of the novel dual endothelin receptor antagonist macitentan in subjects with hepatic or renal impairment

Sidharta, Patricia N., Lindegger, Nicolas, Ulč, Ivan, Dingemanse, Jasper

Journal:

Journal of Clinical Pharmacology

Year:

2014

Language:

english

File:

PDF, 641 KB

english, 2014

13

Single-Dose Pharmacokinetics, Safety, and Tolerability of Macitentan, a New Dual Endothelin Receptor Antagonist, in Subjects With Severe Renal Function Impairment

Sidharta, Patricia, Lindegger, Nicolas, Ulč, Ivan, van Giersbergen, Paul, Dingemanse, Jasper

Journal:

Year:

2012

Language:

english

File:

PDF, 211 KB

english, 2012

14

MultipleâDose Pharmacokinetics, Safety, and Tolerability of Aprocitentan, a Dual Endothelin Receptor Antagonist, in Healthy Japanese and Caucasian Subjects

Fontes, Magda S.C., Dingemanse, Jasper, Sidharta, Patricia N.

Journal:

Clinical Pharmacology in Drug Development

Year:

2020

File:

PDF, 463 KB

2020

15

Population Pharmacodynamic Modeling of Hyperglycemic Clamp and Meal Tolerance Tests in Patients with Type 2 Diabetes Mellitus

Ying Hong, Jasper Dingemanse, Patricia Sidharta, Donald E. Mager

Journal:

The AAPS Journal

Year:

2013

Language:

english

File:

PDF, 884 KB

english, 2013

16

Single-Dose Pharmacokinetics, Safety, and Tolerability of Macitentan, a New Endothelin Receptor Antagonist, in Subjects with Mild, Moderate or Severe Hepatic Impairment

Sidharta, Patricia, Lindegger, Nicolas, van Giersbergen, Paul, Dingemanse, Jasper

Journal:

Year:

2012

Language:

english

File:

PDF, 180 KB

english, 2012

17

Effect of Cyclosporine and Rifampin on the Pharmacokinetics of Macitentan, a Tissue-Targeting Dual Endothelin Receptor Antagonist

Shirin Bruderer, Päivi Äänismaa, Marie-Claude Homery, Stephanie Häusler, Kyle Landskroner, Patricia N. Sidharta, Alexander Treiber, Jasper Dingemanse

Journal:

The AAPS Journal

Year:

2012

Language:

english

File:

PDF, 479 KB

english, 2012

18

A novel CRTH2 antagonist: Single- and multiple-dose tolerability, pharmacokinetics, and pharmacodynamics of ACT-453859 in healthy subjects

Géhin, Martine, Strasser, Daniel S., Zisowsky, Jochen, Farine, Hervé, Groenen, Peter M.A., Dingemanse, Jasper, Sidharta, Patricia N.

Journal:

Journal of Clinical Pharmacology

Year:

2015

Language:

english

File:

PDF, 1.93 MB

english, 2015

19

Development of a decision-making biomarker for CRTH2 antagonism in clinical studies

Strasser, Daniel S., Farine, Hervé, Holdener, Martin, Zisowsky, Jochen, Roscher, René, Hoerner, Julie, Gehin, Martine, Sidharta, Patricia N., Dingemanse, Jasper, Groenen, Peter M.A.

Journal:

New Horizons in Translational Medicine

Year:

2015

Language:

english

File:

PDF, 542 KB

english, 2015

20

[American Thoracic Society American Thoracic Society 2012 International Conference, May 18-23, 2012 • San Francisco, California - ()] C22. ASTHMA THERAPY - Effect Of Multiple-Dose Setipiprant, A Selective Oral CRTH2 Antagonist, On Allergen-Induced Airway Responses In Allergic Asthmatic Patients

Diamant, Zuzana, Singh, David, O'Connor, Brian J., Zuiker, Rob, Ponnarambil, S, Leaker, Brian R., Silkey, Mariabeth, Dingemanse, Jasper, Sidharta, Patricia N.

Year:

2012

Language:

english

File:

PDF, 43 KB

english, 2012

21

Pharmacokinetics of Macitentan in Patients With Pulmonary Arterial Hypertension and Comparison With Healthy Subjects

Issac, Milena, Dingemanse, Jasper, Sidharta, Patricia N.

Journal:

Journal of Clinical Pharmacology

Year:

2017

Language:

english

File:

PDF, 413 KB

english, 2017

22

Pharmacokinetic/Pharmacodynamic Modelling of Receptor Internalization with CRTH2 Antagonists to Optimize Dose Selection

Krause, Andreas, Zisowsky, Jochen, Strasser, Daniel S., Gehin, Martine, Sidharta, Patricia N., Groenen, Peter M. A., Dingemanse, Jasper

Journal:

Clinical Pharmacokinetics

Year:

2016

Language:

english

File:

PDF, 621 KB

english, 2016

23

Relevance of the CXCR4/CXCR7-CXCL12 axis and its effect in pathophysiological conditions

Huynh, Christine, Dingemanse, Jasper, Meyer zu Schwabedissen, Henriette E., Sidharta, Patricia N.

Journal:

Pharmacological Research

Year:

2020

File:

PDF, 1.49 MB

2020

24

Safety, tolerability, pharmacokinetics, and pharmacodynamics of macitentan, an endothelin receptor antagonist, in an ascending multiple-dose study in healthy subjects

Sidharta, Patricia N., van Giersbergen, Paul L. M., Dingemanse, Jasper

Journal:

Journal of Clinical Pharmacology

Year:

2013

Language:

english

File:

PDF, 448 KB

english, 2013

25

Pharmacokinetics and Pharmacodynamics of the Urotensin-II Receptor Antagonist Palosuran in Healthy Male Subjects

Sidharta, Patricia N., van Giersbergen, Paul L. M., Dingemanse, Jasper

Journal:

Journal of Clinical Pharmacology

Year:

2009

Language:

english

File:

PDF, 290 KB

english, 2009

26

Lack of Pharmacokinetic Interactions Between Macitentan and a Combined Oral Contraceptive in Healthy Female Subjects

Hurst, Noémie, Pellek, Matthias, Dingemanse, Jasper, Sidharta, Patricia N.

Journal:

Journal of Clinical Pharmacology

Year:

2016

Language:

english

File:

PDF, 280 KB

english, 2016

27

Pharmacokinetics of Macitentan in Caucasian and Japanese Subjects: The Influence of Ethnicity and Sex

Bruderer, Shirin, Marjason, Joanne, Sidharta, Patricia N., Dingemanse, Jasper

Journal:

Year:

2013

Language:

english

File:

PDF, 470 KB

english, 2013

28

CYP2C9 involvement in ACT-453859 metabolism

Géhin, Martine, Dingemanse, Jasper, Sidharta, Patricia N.

Journal:

Journal of Clinical Pharmacology

Year:

2015

Language:

english

File:

PDF, 90 KB

english, 2015

29

Macitentan: entry-into-humans study with a new endothelin receptor antagonist

Patricia N. Sidharta, Paul L. M. van Giersbergen, Atef Halabi, Jasper Dingemanse

Journal:

European Journal of Clinical Pharmacology

Year:

2011

Language:

english

File:

PDF, 226 KB

english, 2011

30

Single- and multiple-dose tolerability, safety, pharmacokinetics, and pharmacodynamics of the dual endothelin receptor antagonist aprocitentan in healthy adult and elderly subjects

Sidharta, Patricia, Melchior, Meggane, Kankam, Martin K., Dingemanse, Jasper

Journal:

Drug Design Development and Therapy

Year:

2019

File:

PDF, 1.18 MB

2019

31

First-Phase Insulin Secretion Has Limited Impact on Postprandial Glycemia in Subjects with Type 2 Diabetes: Correlations Between Hyperglycemic Glucose Clamp and Meal Test

Rave, Klaus, Sidharta, Patricia N., Dingemanse, Jasper, Heinemann, Lutz, Roggen, Kerstin

Journal:

Diabetes Technology & Therapeutics

Year:

2010

Language:

english

File:

PDF, 278 KB

english, 2010

32

Assessment of Target Engagement in a FirstâinâHuman Trial with Sinbaglustat, an Iminosugar to Treat Lysosomal Storage Disorders

Gehin, Martine, Melchior, Meggane, Welford, Richard W.D., Sidharta, Patricia N., Dingemanse, Jasper

Journal:

Clinical and Translational Science

Year:

2020

File:

PDF, 571 KB

2020

33

Pharmacokinetic and pharmacodynamic evaluation of macitentan, a novel endothelin receptor antagonist for the treatment of pulmonary arterial hypertension

Sidharta, Patricia N, Krähenbühl, Stephan, Dingemanse, Jasper

Journal:

Expert Opinion on Drug Metabolism & Toxicology

Year:

2015

Language:

english

File:

PDF, 558 KB

english, 2015

34

Bosentan Pharmacokinetics in Pediatric Patients with Pulmonary Arterial Hypertension: Comparison of Dried Blood Spot and Plasma Analysis

Géhin, Martine, Sidharta, Patricia N., Dingemanse, Jasper

Journal:

Year:

2016

Language:

english

File:

PDF, 121 KB

english, 2016

35

Pharmacokinetics, pharmacodynamics, tolerability and prediction of clinically effective dose of ACT-774312, a novel CRTH2 antagonist

Géhin, Martine, Lott, Dominik, Farine, Hervé, Issac, Milena, Strasser, Daniel, Sidharta, Patricia, Dingemanse, Jasper

Journal:

Basic & Clinical Pharmacology & Toxicology

Year:

2018

Language:

english

File:

PDF, 603 KB

english, 2018

36

Effect of the urotensin-II receptor antagonist palosuran on secretion of and sensitivity to insulin in patients with Type 2 diabetes mellitus

Patricia N. Sidharta, Klaus Rave, Lutz Heinemann, Eleonora Chiossi, Stephan Krähenbühl, Jasper Dingemanse

Journal:

British Journal of Clinical Pharmacology

Year:

2009

Language:

english

File:

PDF, 759 KB

english, 2009

37

Investigation of mutual pharmacokinetic interactions between macitentan, a novel endothelin receptor antagonist, and sildenafil in healthy subjects

Sidharta, Patricia N., van Giersbergen, Paul L. M., Wolzt, Michael, Dingemanse, Jasper

Journal:

British Journal of Clinical Pharmacology

Year:

2014

Language:

english

File:

PDF, 1.23 MB

english, 2014

38

Multiple-Dose Pharmacokinetics, Pharmacodynamics, and Safety of the Urotensin-II Receptor Antagonist Palosuran in Healthy Male Subjects

Sidharta, Patricia N., van Giersbergen, Paul L.M., Dingemanse, Jasper

Journal:

Year:

2018

Language:

english

File:

PDF, 307 KB

english, 2018

39

Relative bioavailability of a pediatric dispersible tablet and adult filmâcoated tablet of macitentan in healthy volunteers

Sidharta, Patricia N., Å tÄpÃ¡novÃ¡, Radka, Globig, Susanne, UlÄ, Ivan, Csonka, DÃ©nes

Journal:

Pharmacology Research & Perspectives

Year:

2020

File:

PDF, 1.18 MB

2020

40

Effect of Multiple-Dose Aprocitentan Administration on the Pharmacokinetics of Midazolam in Healthy Male Subjects

Sidharta, Patricia N., Dingemanse, Jasper

Journal:

European Journal of Drug Metabolism and Pharmacokinetics

Year:

2019

File:

PDF, 713 KB

2019

41

Effects of MultipleâDose Administration of Aprocitentan on the Pharmacokinetics of Rosuvastatin

Sidharta, Patricia N., Dingemanse, Jasper

Journal:

Clinical Pharmacology in Drug Development

Year:

2020

File:

PDF, 536 KB

2020

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