Výsledky vyhledávání - "Donna Kowalski"

The Influence of Hepatic and Renal Impairment on the Pharmacokinetics of a Treatment for Herpes Zoster, Amenamevir (ASP2151): Phase 1, Open-Label, Single-Dose, Parallel-Group Studies

Autor: Richard A. Preston, Masataka Katashima, Michaelene Lewand, Akitsugu Takada, Thomas Marbury, Donna Kowalski, James Keirns, Kota Kato, Kenneth C. Lasseter, Tomohiro Kusawake

Publikováno v: Advances in Therapy

Introduction Amenamevir (ASP2151) is a nonnucleoside human herpesvirus helicase-primase inhibitor that was approved in Japan for the treatment of herpes zoster (shingles) in 2017. This article reports the results of two clinical trials that investiga

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::ec0bcaeb238a377599df9c8a9dd706b7
https://doi.org/10.1007/s12325-017-0643-3

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Pharmacokinetics and Safety of Amenamevir in Healthy Subjects: Analysis of Four Randomized Phase 1 Studies

Autor: Dorien Groenendaal-van de Meent, Akitsugu Takada, Tomohiro Kusawake, Donna Kowalski, James Keirns, Masataka Katashima, Martin den Adel, Yoshiaki Ohtsu

Publikováno v: Advances in Therapy

Introduction Amenamevir (ASP2151) is a nonnucleoside antiherpesvirus compound available for the treatment of varicella–zoster virus infections. In this article we summarize the findings of four phase 1 studies in healthy participants. Methods Four

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::f85da21f76a6ac6925ba311ad2a6805b
https://doi.org/10.1007/s12325-017-0642-4

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Two Phase 1, Open‐Label, Mass Balance Studies to Determine the Pharmacokinetics of 14C‐Labeled Isavuconazonium Sulfate in Healthy Male Volunteers

Autor: Amit Desai, Shahzad Akhtar, Kota Kato, Robert Townsend, Donna Kowalski, Takao Yamazaki, Christine Hale, Christopher Lademacher

Publikováno v: Clinical Pharmacology in Drug Development

Isavuconazonium sulfate is the water‐soluble prodrug of the active triazole isavuconazole. Two phase 1 studies were conducted to identify the metabolic profile and mass balance of isavuconazole and BAL8728 (inactive cleavage product). Seven subject

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::08c40fea7b3009991d40f7d5347442cd
http://europepmc.org/articles/PMC5811773

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QT Interval Shortening With Isavuconazole: In Vitro and In Vivo Effects on Cardiac Repolarization

Autor: Peter R. Kowey, Takao Yamazaki, Mark Yen, Salim Mujais, Christopher Lademacher, Amit Desai, Tomasz Wojtkowski, B Parker, Robert Townsend, Donna Kowalski, James Keirns, Marlowe J. Schneidkraut

Publikováno v: Clinical Pharmacology and Therapeutics

The effects of isavuconazole (active moiety of isavuconazonium sulfate) on cardiac ion channels in vitro and cardiac repolarization clinically were assessed in a phase I, randomized, double‐blind study in healthy individuals who received isavuconaz

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::e55044171cfe9344ae884a245a4014bc
https://doi.org/10.1002/cpt.620

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No Dose Adjustment for Isavuconazole Based on Age or Sex

Autor: Christopher Lademacher, Amit Desai, Helene Pearlman, Donna Kowalski, David Han, Takao Yamazaki

Publikováno v: Antimicrobial Agents and Chemotherapy

This phase 1, open-label, single-dose, parallel-group study evaluated the pharmacokinetics (PK) of isavuconazole after a single oral dose of the prodrug isavuconazonium sulfate in healthy nonelderly (age, 18 to 45 years) and elderly (age, ≥65 years

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::e608685cf7c292f0f34fb6502ef3dd8d
https://doi.org/10.1128/aac.02629-18

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Pharmacokinetic and Pharmacodynamic Evaluation of the Drug-Drug Interaction Between Isavuconazole and Warfarin in Healthy Subjects

Autor: Albert J. Dietz, Robert Townsend, Christopher Lademacher, Donna Kowalski, Amit Desai, Helene Pearlman, Shahzad Akhtar, Takao Yamazaki

Publikováno v: Clinical Pharmacology in Drug Development. 6:86-92

This phase 1 trial evaluated pharmacokinetic and pharmacodynamic interactions between the novel triazole antifungal agent isavuconazole and warfarin in healthy adults. Multiple doses of isavuconazole were administered as the oral prodrug, isavuconazo

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::07608147e8c72262110e6e3ea583c7a0
https://doi.org/10.1002/cpdd.283

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Isavuconazole absorption following oral administration in healthy subjects is comparable to intravenous dosing, and is not affected by food, or drugs that alter stomach pH

Autor: Donna Kowalski, Amit Desai, Helene Pearlman, Takao Yamazaki, Robert Townsend, Anne Schmitt-Hoffmann

Publikováno v: Int. Journal of Clinical Pharmacology and Therapeutics. 54:572-580

Objective/methods Two openlabel, single-dose, randomized crossover studies and one open-label, multiple-dose, parallel group study in healthy volunteers were conducted with the prodrug, isavuconazonium sulfate, to determine absolute bioavailability o

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::071c4f5c743e7f9ef63b9794d2955080
https://doi.org/10.5414/cp202434

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Pharmacokinetic Assessment of Drug-Drug Interactions of Isavuconazole With the Immunosuppressants Cyclosporine, Mycophenolic Acid, Prednisolone, Sirolimus, and Tacrolimus in Healthy Adults

Autor: Amit Desai, Takao Yamazaki, Kota Kato, Andreas H. Groll, Debra Mandarino, Corrie Howieson, Shahzad Akhtar, David Han, Christopher Lademacher, William Lewis, Robert Townsend, Donna Kowalski, Helene Pearlman

Publikováno v: Clinical Pharmacology in Drug Development. 6:76-85

This report summarizes phase 1 studies that evaluated pharmacokinetic interactions between the novel triazole antifungal agent isavuconazole and the immunosuppressants cyclosporine, mycophenolic acid, prednisolone, sirolimus, and tacrolimus in health

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::83239e123fe139b627a277844038c1f7
https://doi.org/10.1002/cpdd.284

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Pharmacokinetic Evaluation of CYP3A4-Mediated Drug-Drug Interactions of Isavuconazole With Rifampin, Ketoconazole, Midazolam, and Ethinyl Estradiol/Norethindrone in Healthy Adults

Autor: Helene Pearlman, Amit Desai, Kenneth C. Lasseter, Christopher Lademacher, Christine Hale, Donna Kowalski, Shahzad Akhtar, Anne Schmitt-Hoffmann, Albert J. Dietz, Robert Townsend, Diane Rammelsberg, Takao Yamazaki

Publikováno v: Clinical Pharmacology in Drug Development. 6:44-53

This report describes the phase 1 trials that evaluated the metabolism of the novel triazole antifungal isavuconazole by cytochrome P450 3A4 (CYP3A4) and isavuconazole's effects on CYP3A4-mediated metabolism in healthy adults. Coadministration of ora

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::5c1f5aa7377157f0f9e2ca74eb611ea4
https://doi.org/10.1002/cpdd.285

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Pharmacokinetic Interaction Between Isavuconazole and a Fixed-Dose Combination of Lopinavir 400 mg/Ritonavir 100 mg in Healthy Subjects

Autor: Amit Desai, Robert Townsend, David Han, Donna Kowalski, Laura L. Kovanda, Kota Kato, Shahzad Akhtar, Takao Yamazaki, Christopher Lademacher

Publikováno v: Clinical Pharmacology in Drug Development. 6:93-101

This phase 1, open-label study evaluated the pharmacokinetic effects of coadministration of the antifungal agent, isavuconazole (administered as its water-soluble prodrug isavuconazonium sulfate), with the antiretroviral agent lopinavir/ritonavir in

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::ab2f9d7c08a3416d57860ec82f900437
https://doi.org/10.1002/cpdd.282

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