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Effect of Dietary Intake on the Pharmacokinetics of the Multitargeted Receptor Tyrosine Kinase Inhibitor Famitinib: Results From a Phase 1 Study in Healthy Chinese Participants
In conclusion, oral famitinib bioavailability is not affected by food intake, implying that patients with cancer do not need to consider dietary status when using famitinib. This is considered important for convenience and treatment compliance. (Source: Clinical Pharmacology in Drug Development)
Source: Clinical Pharmacology in Drug Development - March 4, 2023 Category: Drugs & Pharmacology Authors: Xiaoran Zhang, Gexin Shi, Shaorong Li, Jing Rao, Qing Wen, Hengli Zhao Tags: Original Article Source Type: research

First ‐in‐Human, Single‐ and Multiple‐Ascending‐Dose, Food‐Effect, and Absolute Bioavailability Trials to Assess the Pharmacokinetics, Safety, and Tolerability of Pritelivir, a Nonnucleoside Helicase‐Primase Inhibitor Against Herpes Simplex Virus in Healthy Subjects
AbstractThe pharmacokinetics and safety of the novel herpes simplex virus helicase-primase inhibitor pritelivir were evaluated in 5 phase 1 trials: a single-ascending-dose trial, 2 multiple-ascending-dose trials, a food-effect trial, and an absolute bioavailability trial in healthy male subjects. One cohort of healthy female subjects was included in the single-ascending-dose trial. Pritelivir pharmacokinetics were linear up to 480  mg following single and up to 400 mg following multiple once-daily doses. The half-life ranged from 52 to 83 hours, and steady state was reached between 8 and 13 days. Maximum plasma concent...
Source: Clinical Pharmacology in Drug Development - March 2, 2023 Category: Drugs & Pharmacology Authors: Dirk Kropeit, Susanne Bonsmann, Oliver Richter, David McCormick, J örg Pausch, Melanie Sumner, Alexander Birkmann, Holger Zimmermann, Helga Rübsamen‐Schaeff Tags: Original Article Source Type: research

Issue Information
(Source: Clinical Pharmacology in Drug Development)
Source: Clinical Pharmacology in Drug Development - March 1, 2023 Category: Drugs & Pharmacology Tags: Issue Information Source Type: research

2022 CPDD Reviewers
(Source: Clinical Pharmacology in Drug Development)
Source: Clinical Pharmacology in Drug Development - March 1, 2023 Category: Drugs & Pharmacology Tags: List of Reviewers Source Type: research

Issue Information
(Source: Clinical Pharmacology in Drug Development)
Source: Clinical Pharmacology in Drug Development - March 1, 2023 Category: Drugs & Pharmacology Tags: Issue Information Source Type: research

Effect of Multiple Doses of Sparsentan on the Single ‐Dose Pharmacokinetics of Dapagliflozin: An Open‐Label Drug–Drug Interaction Study in Healthy Adults
AbstractSparsentan is a single-molecule dual antagonist of the endothelin type A receptor and angiotensin II type 1 receptor under investigation for the treatment of focal segmental glomerulosclerosis and immunoglobulin A nephropathy. Dapagliflozin, a sodium-glucose cotransporter 2 inhibitor, has recently been indicated in chronic kidney disease. Sparsentan may be considered for concomitant use with dapagliflozin. The purpose of this open-label, 1-sequence crossover study was to determine whether drug –drug interactions between sparsentan and dapagliflozin affect dapagliflozin pharmacokinetics (PK). In addition, exposure...
Source: Clinical Pharmacology in Drug Development - March 1, 2023 Category: Drugs & Pharmacology Authors: Shang ‐Chiung Chen, Danlin Cai, Claire Winnett, Mai Nguyen, Neeraj Verma, Kai Liu, Priscila Preciado Tags: Original Article Source Type: research

The Oral Bioavailability and Effect of Various Gastric Conditions on the Pharmacokinetics of Dersimelagon in Healthy Adult Volunteers
AbstractDersimelagon is a novel orally administered selective agonist for melanocortin receptor 1 being investigated for the treatment of erythropoietic protoporphyria, X-linked protoporphyria, and diffuse cutaneous systemic sclerosis. In this open-label, multicenter, randomized, two-cohort, sequential crossover study, the relative oral bioavailability of two tablet formulations of dersimelagon was evaluated, and the effect of various gastric conditions (from a high-fat meal, a proton-pump inhibitor, and an acidic carbonated beverage) on the pharmacokinetics of dersimelagon were assessed in healthy participants (N  = 50)...
Source: Clinical Pharmacology in Drug Development - February 26, 2023 Category: Drugs & Pharmacology Authors: Kei Ogawa, Ryosuke Ide, Kirstine Belongie, Minoru Tsuda, Hiroki Kawanishi, Renli Teng, Akihito Ogasawara Tags: Original Article Source Type: research

A Bioequivalence Study With Pharmacokinetic Endpoints for Azithromycin Eye Drops
In this study, we compared the pharmacokinetic properties and assessed the bioequivalence of a newly developed generic azithromycin eye drop with a branded formulation. This open-label, single-dose, randomized, crossover, sparse-sampling ocular bioequivalence study was conducted on 48 healthy Chinese volunteers. Tear samples were collected for up to 36  hours, and each participant was randomly allocated to one of the prespecified sampling times. Tear drug concentrations were determined using a validated liquid chromatography-tandem mass spectrometry method. The pharmacokinetic parameters were calculated via noncompartment...
Source: Clinical Pharmacology in Drug Development - February 23, 2023 Category: Drugs & Pharmacology Authors: Feng Wu, Xiuli Zhao, Shaojie Guo, Siyang Ni, Yuyang Dai, Ying Han, Ke Ma, Yunzhe Wang Tags: Original Article Source Type: research

Authorship in Academic Literature
(Source: Clinical Pharmacology in Drug Development)
Source: Clinical Pharmacology in Drug Development - February 23, 2023 Category: Drugs & Pharmacology Authors: Jaime A. Teixeira da Silva Tags: Letter to the Editor Source Type: research