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Prediction of Pediatric Pharmacokinetics for CYP3A4 Metabolized Drugs: Comparison of the Performance of Two Hepatic Ontogeny Within a Physiologically Based Pharmacokinetic Model
This study broadens the evidence from previous studies that Upreti is more favorable than Salem, but further work is needed especially in the neonatal and early infant age range.PMID:38696325 | DOI:10.1002/jcph.2452 (Source: The Journal of Clinical Pharmacology)
Source: The Journal of Clinical Pharmacology - May 2, 2024 Category: Drugs & Pharmacology Authors: Marc Codaccioni Rosalind L Southall Jean Dinh Trevor N Johnson Source Type: research

Pharmacokinetic, Pharmacodynamic, and Safety Profiles of Proline Henagliflozin in Chinese Subjects with Varying Degrees of Liver Dysfunction
J Clin Pharmacol. 2024 Apr 30. doi: 10.1002/jcph.2437. Online ahead of print.ABSTRACTProline henagliflozin, a novel selective inhibitor of sodium glucose cotransporter 2, is a treatment for type 2 diabetes mellitus. We designed a parallel-group, open-label, and multicenter study to evaluate the pharmacokinetic (PK), pharmacodynamic (PD), and safety profiles of henagliflozin in Chinese subjects with varying degrees of liver dysfunction. Thirty-two subjects were enrolled and divided into four groups based on liver function (normal liver function, mild, moderate, or severe liver dysfunction). The area under the plasma concent...
Source: The Journal of Clinical Pharmacology - April 30, 2024 Category: Drugs & Pharmacology Authors: Likun Ding Lin Yang Danjun Ren Xiaohua Gao Juanli Zhang Meiyou Liu Li Sun Qingbo Diao Sheng Feng Aidong Wen Jingwen Wang Source Type: research

Assessing Pharmacogenomic loci Associated with the Pharmacokinetics of Vamorolone in Boys with Duchenne Muscular Dystrophy
J Clin Pharmacol. 2024 Apr 29. doi: 10.1002/jcph.2446. Online ahead of print.ABSTRACTHuman genetic variation (polymorphisms) in genes coding proteins involved in the absorption, distribution, metabolism, and elimination (ADME) of drugs can have a strong effect on drug exposure and downstream efficacy and safety outcomes. Vamorolone, a dissociative steroidal anti-inflammatory drug for treating Duchenne muscular dystrophy (DMD), primarily undergoes oxidation by CYP3A4 and CYP3A5 and glucuronidation by UDP-glucuronosyltransferases. This work assesses the pharmacokinetics (PKs) of vamorolone and sources of interindividual vari...
Source: The Journal of Clinical Pharmacology - April 29, 2024 Category: Drugs & Pharmacology Authors: Xiaonan Li Daniele Sabbatini Elena Pegoraro Luca Bello Paula Clemens Michela Guglieri John van den Anker Jesse Damsker John McCall Utkarsh J Dang Eric P Hoffman William J Jusko Source Type: research

Relative Bioavailability of Cenobamate Administered as a Crushed Tablet, Either Orally or via Nasogastric Tube, versus an Intact Whole Tablet
J Clin Pharmacol. 2024 Apr 29. doi: 10.1002/jcph.2439. Online ahead of print.ABSTRACTCenobamate is approved for the treatment of focal seizures in adults and is currently available as an oral tablet. Alternative methods of drug administration are needed for patients who are unable to swallow whole intact tablets. This phase 1, open-label, randomized, single-dose, three-way crossover (3-period, 3-treatment, 6-sequence) study (NCT05572255), conducted in healthy volunteers, assessed the relative bioavailability of a crushed 200-mg cenobamate tablet administered orally or via nasogastric (NG) tube compared with an intact 200-m...
Source: The Journal of Clinical Pharmacology - April 29, 2024 Category: Drugs & Pharmacology Authors: Vijay Vashi Janice Laramy Marc Kamin Louis Ferrari Alan Hand Source Type: research

Effect of Histamine H2 Receptor Antagonists on All-Cause Mortality in Critically Ill Patients With Essential Hypertension: A Retrospective Cohort Study
In conclusion, H2RAs exposure was related to lower mortalities in critically ill patients with essential hypertension, which provided novel potential strategy for the use of H2RAs in essential hypertension patients.PMID:38659369 | DOI:10.1002/jcph.2445 (Source: The Journal of Clinical Pharmacology)
Source: The Journal of Clinical Pharmacology - April 25, 2024 Category: Drugs & Pharmacology Authors: Jian-Mei Pan Yu Guo Fang-Fang Jiang Ran Xu Xin Zhang Wen-Ke Cai Sun-Jun Yin Ping Wang Yan-Hua Huang Xue-Sha Zhang Yi-Hua Li Liao Cai Gong-Hao He Source Type: research

Impact of CYP2C19, CYP2C9, CYP3A4, and FMO3 Genetic Polymorphisms and Sex on the Pharmacokinetics of Voriconazole after Single and Multiple Doses in Healthy Chinese Subjects
J Clin Pharmacol. 2024 Apr 23. doi: 10.1002/jcph.2440. Online ahead of print.ABSTRACTVoriconazole is the first-line treatment for invasive aspergillosis. Its pharmacokinetics exhibit considerable inter- and intra-individual variability. The purpose of this study was to investigate the effects of CYP2C19, CYP2C9, CYP3A4, and FMO3 genetic polymorphisms and sex on the pharmacokinetics of voriconazole in healthy Chinese adults receiving single-dose and multiple-dose voriconazole, to provide a reference for its clinical individualized treatment. A total of 123 healthy adults were enrolled in the study, with 108 individuals and ...
Source: The Journal of Clinical Pharmacology - April 24, 2024 Category: Drugs & Pharmacology Authors: Shuaibing Liu Xia Yao Jun Tao Shiyu Zhao Suke Sun Suyun Wang Xin Tian Source Type: research

Single- and Multiple-Dose Pharmacokinetics of Gefapixant (MK-7264), a P2X3 Receptor Antagonist, in Healthy Adults
J Clin Pharmacol. 2024 Apr 23. doi: 10.1002/jcph.2442. Online ahead of print.ABSTRACTGefapixant (MK-7264, RO4926219, AF-219) is a first-in-class P2X3 antagonists being developed to treat refractory or unexplained chronic cough. The initial single- and multiple-dose safety, tolerability, and pharmacokinetics of gefapixant at doses ranging from 7.5 to 1800 mg were assessed in four clinical trials. Following single-dose administration of 10-450 mg, the pharmacokinetic (PK) profile of gefapixant in plasma and urine demonstrated low inter-subject variability and a dose-proportional exposure. Following administration of multiple...
Source: The Journal of Clinical Pharmacology - April 23, 2024 Category: Drugs & Pharmacology Authors: Jesse C Nussbaum Azher Hussain Peter Butera Anthony P Ford Michael M Kitt Edward A O'Neill Steven Smith Gabriel Vargas Terry O'Reilly Chris Wynne S Aubrey Stoch Marian Iwamoto Source Type: research

Characterizing the Nonlinear Pharmacokinetics and Pharmacodynamics of BI 187004, an 11 β-Hydroxysteroid Dehydrogenase Type 1 Inhibitor, in Humans by a Target-Mediated Drug Disposition Model
This study aimed to construct a TMDD model to explain the complex nonlinear PK behavior and underscore the importance of recognizing TMDD in this small-molecule compound. Among the various models explored, the best model was a two-compartment TMDD model with three transit absorption components. The final model provides insights into 11β-HSD1 binding-related parameters for BI 187004, including the total amount of 11β-HSD1 in the liver (estimated to be 8000 nmol), the second order association rate constant (estimated to be 0.102 nM-1h-1), and the first-order dissociation rate constant (estimated to be 0.11 h-1). Our final ...
Source: The Journal of Clinical Pharmacology - April 23, 2024 Category: Drugs & Pharmacology Authors: Xuanzhen Yuan Guohua An Source Type: research