Results 231 to 240 of about 240,598 (262)

Effect of Mild to Moderate Hepatic Impairment on Valemetostat Pharmacokinetics: An Open‐Label, Phase I Study

open access: yesClinical Pharmacology in Drug Development, EarlyView.
Abstract Valemetostat tosylate (valemetostat) is a dual inhibitor of enhancer of zeste homolog (EZH) 2 and EZH1, approved in Japan for the treatment of relapsed/refractory peripheral T‐cell lymphoma and adult T‐cell leukemia/lymphoma. This Phase I, open‐label study evaluated the pharmacokinetics and safety of a single 50‐mg oral dose of valemetostat in
Masaya Tachibana   +8 more
wiley   +1 more source

Microtracer‐Based Assessment of the Mass Balance, Pharmacokinetics, and Excretion of [14C]Berzosertib, an Intravenous ATR Inhibitor, in Patients With Advanced Solid Tumors: A Phase 1 Study

open access: yesClinical Pharmacology in Drug Development, EarlyView.
Abstract Berzosertib is a small‐molecule ataxia telangiectasia and Rad3‐related protein inhibitor. To assess the clearance mechanism(s) of berzosertib, a Phase 1, 2‐period, open‐label study was conducted in adults with advanced solid tumors who were treated with a single intravenous dose of 210 mg/m2 berzosertib containing approximately 3 µCi of [14C ...
Jayaprakasam Bolleddula   +12 more
wiley   +1 more source

Night‐Time Chronotherapy with Methylprednisolone Prevents an Acute Rejection in Pediatric Patients with Liver Transplantation: A Randomized Clinical Trial

open access: yesClinical Pharmacology &Therapeutics, EarlyView.
Concept of methylprednisolone chronotherapy to prevent acute rejections. While endogenous cortisol secretion rises in the early morning, the number of lymphocytes in the blood is higher at night, thus exhibiting an antiphase pattern to cortisol secretion. Therefore, compared with the daytime, the infiltration of lymphocytes into immune‐reactive tissues
Kentaro Ushijima   +11 more
wiley   +1 more source

Dose Selection for DuoBody®‐CD40x4‐1BB (GEN1042/BNT312) Using a mPBPK/RO Model Leveraging Preclinical and Clinical Data

open access: yesClinical Pharmacology &Therapeutics, EarlyView.
Optimizing target engagement for bispecific antibodies (bsAbs) is challenging, as bsAbs bind to two different targets in vivo to form a trimolecular complex (trimer), and likely display a bell‐shaped concentration–response curve. bsAbs trimer formation is expected to be related to efficacy and safety, and determining the dose level at which it is ...
Gaurav Bajaj   +16 more
wiley   +1 more source

Confirmation of Fixed Quarterly Riliprubart Regimen in Patients with Cold Agglutinin Disease Using Population PK/PD and Exposure‐Response Analyses

open access: yesClinical Pharmacology &Therapeutics, EarlyView.
Riliprubart is a second‐generation, humanized immunoglobulin G4 that inhibits only the activated form of the C1s component of the proximal classical complement pathway. The clinical studies of riliprubart conducted thus far for the treatment of cold agglutinin disease (CAD), a rare autoimmune disease, include a Phase 1 first‐in‐human study in healthy ...
Timothy Chow   +3 more
wiley   +1 more source

Use of PopPK and E‐R Analyses toward Explaining Causal Link Between ADAMTS13 in Recombinant vs. Plasma‐Based Therapies and Clinical Effects in cTTP

open access: yesClinical Pharmacology &Therapeutics, EarlyView.
Congenital thrombotic thrombocytopenic purpura (cTTP) is an ultra‐rare, potentially life‐threatening condition caused by a deficiency of the blood enzyme ADAMTS13. Until now, ADAMTS13 replacement has been achieved with infusions of plasma or plasma‐based therapies (PBT).
Munjal Patel   +11 more
wiley   +1 more source

Microbiome‐Informed Dosing: Exploring Gut Microbial Communities Impact on Mycophenolate Enterohepatic Circulation and Therapeutic Target Achievement

open access: yesClinical Pharmacology &Therapeutics, EarlyView.
Pharmacomicrobiomics is an emerging field due to important microbiome effects on pharmacokinetics and clinical outcomes. However, the application of this knowledge remains limited. Mycophenolic acid (MPA) is the primary active metabolite of the immunosuppressant, mycophenolate mofetil (MMF).
Abdelrahman Saqr   +4 more
wiley   +1 more source

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