Comment on: Anti-Coagulant Treatment of Cancer-Associated Thrombosis in Frail Patients: Impact of Frailties on the Management of Drug –Drug Interactions
(Source: Clinical Pharmacokinetics)
Source: Clinical Pharmacokinetics - January 18, 2024 Category: Drugs & Pharmacology Source Type: research
Pharmacokinetics, Disposition, and Biotransformation of [14C]Lenacapavir, a Novel, First-in-Class, Selective Inhibitor of HIV-1 Capsid Function, in Healthy Participants Following a Single Intravenous Infusion
ConclusionsThe results of this mass balance study indicated that LEN was majorly eliminated as intact LEN via the feces. The renal pathway played a minor role in LEN elimination (0.24%). In addition, no major circulating metabolites in plasma or feces were found, indicating minimal metabolism of LEN. (Source: Clinical Pharmacokinetics)
Source: Clinical Pharmacokinetics - January 18, 2024 Category: Drugs & Pharmacology Source Type: research
Population Pharmacokinetic Modeling of Cotadutide: A Dual Agonist Peptide of Glucagon-Like Peptide and Glucagon Receptors Administered to Participants with Type II Diabetes Mellitus, Chronic Kidney Disease, Obesity and Non-Alcoholic Steatohepatitis
ConclusionsA popPK model was developed for cotadutide with cotadutide clinical data, and the impact of the statistically significant covariates identified was not considered clinically meaningful. The popPK model will be used to evaluate exposure –response relationships for cotadutide clinical data. (Source: Clinical Pharmacokinetics)
Source: Clinical Pharmacokinetics - January 18, 2024 Category: Drugs & Pharmacology Source Type: research
Safety and Pharmacokinetics of HRS-2261, a P2X3 Receptor Antagonist, in Healthy Subjects: A Randomized, Double-Blind, Placebo-Controlled Phase 1 Study
ConclusionsHRS-2261 demonstrated good tolerability, with a low incidence of dysgeusia. The PK profile was favorable. This study supports further development of HRS-2261 as a potential P2X3 receptor antagonist for chronic cough.Trial Registration NumberClinical trials.gov, identifier: NCT05274516. Trial registration date: March 10, 2022. (Source: Clinical Pharmacokinetics)
Source: Clinical Pharmacokinetics - January 10, 2024 Category: Drugs & Pharmacology Source Type: research
Pharmacokinetics, Pharmacodynamics, and Safety of Single Dose HSK7653 Tablets in Chinese Subjects with Normal or Impaired Renal Function
ConclusionsHSK7653 is a potent oral DPP-4 inhibitor with a long plasma half-life, supporting a dosing regimen of once every 2 weeks. Impaired renal function does not appear to impact the pharmacokinetic and pharmacodynamic properties of HSK7653 after a single administration in Chinese subjects. HSK7653 is also well tolerated without an increase in adverse events with increasing renal impairment. These results indicate that dose adjustment of HSK7653 may not be required in patients with renal impairment.Trial RegistrationClinicalTrials.gov Identifier: NCT05497297. (Source: Clinical Pharmacokinetics)
Source: Clinical Pharmacokinetics - January 6, 2024 Category: Drugs & Pharmacology Source Type: research
Patients with Obesity Should be Recognised as a Special Patient Population During Drug Development of Antibacterial and Antifungal Agents; A Call to Action
AbstractIndividuals with obesity are at increased risk of developing infectious diseases. Timely administration of an effective dose of an antimicrobial agent is paramount to safeguard optimal therapy. For this purpose, special patient populations at risk for altered exposure such as renal or hepatic impairment are studied during drug development. Strikingly, there is no such evaluation in individuals with obesity despite a potential influence on exposure and a global obesity prevalence of 13 %. Optimal clinical decision making in patients with obesity is impossible without prior study of the drug of interest in this popul...
Source: Clinical Pharmacokinetics - January 5, 2024 Category: Drugs & Pharmacology Source Type: research
A Comprehensive Review of the Clinical Pharmacokinetics, Pharmacodynamics, and Drug Interactions of Nirmatrelvir/Ritonavir
AbstractNirmatrelvir is a potent and selective inhibitor of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) main protease that is used as an oral antiviral coronavirus disease 2019 (COVID-19) treatment. To sustain unbound systemic trough concentrations above the antiviral in vitro 90% effective concentration value (EC90), nirmatrelvir is coadministered with 100 mg of ritonavir, a pharmacokinetic enhancer. Ritonavir inhibits nirmatrelvir ’s cytochrome P450 (CYP) 3A4-mediated metabolism which results in renal elimination becoming the primary route of nirmatrelvir elimination when dosed concomitantly. Nirma...
Source: Clinical Pharmacokinetics - January 4, 2024 Category: Drugs & Pharmacology Source Type: research
Factors Influencing Unfractionated Heparin Pharmacokinetics and Pharmacodynamics During a Cardiopulmonary Bypass
ConclusionsThe population model effectively characterized UFH ’s pharmacokinetics/pharmacodynamics in cardiopulmonary bypass patients. This meta-analysis incorporated new covariates related to UFH’s pharmacokinetics/pharmacodynamics, enabling personalized dosing regimens. The proposed model holds potential for individualization using a Bayesian estimation. (Source: Clinical Pharmacokinetics)
Source: Clinical Pharmacokinetics - January 2, 2024 Category: Drugs & Pharmacology Source Type: research
Model-Informed Precision Dosing to Reduce Vincristine-Induced Peripheral Neuropathy in Pediatric Patients: A Pharmacokinetic and Pharmacodynamic Modeling and Simulation Analysis
ConclusionsThe PK and PKPD analysis supports the use of MIPD to guide clinical dose decisions and reduce the incidence of VIPN. The current work can be used to support decisions with respect to dose selection and dose individualization in children receiving vincristine. (Source: Clinical Pharmacokinetics)
Source: Clinical Pharmacokinetics - December 23, 2023 Category: Drugs & Pharmacology Source Type: research
