First-in-human, phase I single-ascending-dose study of the safety, pharmacokinetics, and relative bioavailability of selatinib, a dual EGFR-ErbB2 inhibitor in healthy subjects

SummaryWe assessed the pharmacokinetics and safety of a single oral administration of selatinib to healthy Chinese subjects and evaluated the potential bioavailability advantage of selatinib relative to lapatinib. Healthy subjects aged 18 –40 years were enrolled in this two-part study: Part 1, a single ascending dose (50–500 mg), randomized, double-blind, placebo-control study with 64 subjects; and Part 2, an open-label, positive control, randomized, three-treatment, three-period, three-sequence crossover design study, with 6 s ubjects administered a single 500-mg dose of selatinib tablets (A), selatinib suspension (B), or lapatinib tablets C) per cycle. In part 1, selatinib was well-tolerated up to the planned maximum dose of 500 mg; thus the maximum tolerated dose was not attained. Twenty-two adverse events were observe d in 19 (36.5%) of the 52 subjects administered the test drug. The most common drug-related adverse event was diarrhea. The mean selatinib peak plasma concentration was 69.4–494 ng/mL, which was achieved in a median peak time of 3.5–4.5 h, with a mean elimination half-life between 13.8 and 15. 8 h. In Part 2, A and B showed similar bioavailability. Plasma exposure to the active drug (selatinib plus the metabolite, lapatinib) after A intake was more than two-fold higher than that of the same dose of C. In the dose range of 50–500 mg, selatinib was safe and well-tolerated by healthy Chi nese subj...
Source: Investigational New Drugs - Category: Drugs & Pharmacology Source Type: research

Related Links:

This article aims to introduce forensic practitioners to basic concepts in genetics and epigenetics so that they are able to engage with the relevant literature and understand the far-reaching implications for forensic practice. It is becoming increasingly useful for forensic practitioners to appreciate how life experiences are encoded into biology through epigenetics. This paper highlights the potential of genetic and epigenetic research to provide major contributions to real-world practice in the coming years. It provides a modern biopsychosocial perspective on harmful behaviour and helps deepen the understanding of o...
Source: Journal of Forensic Practice - Category: Forensic Medicine Authors: Source Type: research
In the article, “Nutritional Management for Dogs and Cats with Chronic Kidney Disease,” by Valerie J. Parker, published in the May 2021 issue (Volume 51, number 3, pages 685-710), in Table 3 on page 12, for the “2020 AAFCO Feline adult maintenance maximum requirement” under the “Vitamin D (IU)”, the co rrect number should be 752 instead of 75.2.
Source: Veterinary Clinics of North America: Small Animal Practice - Category: Veterinary Research Source Type: research
Diagnostic Imaging: Point-of-Care Ultrasound
Source: Veterinary Clinics of North America: Small Animal Practice - Category: Veterinary Research Source Type: research
Christopher A. Adin and Kelly D. Farnsworth
Source: Veterinary Clinics of North America: Small Animal Practice - Category: Veterinary Research Source Type: research
CHRISTOPHER A. ADIN, DVM
Source: Veterinary Clinics of North America: Small Animal Practice - Category: Veterinary Research Source Type: research
Elsevier
Source: Veterinary Clinics of North America: Small Animal Practice - Category: Veterinary Research Source Type: research
VETERINARY CLINICS OF NORTH AMERICA: SMALL ANIMAL PRACTICE
Source: Veterinary Clinics of North America: Small Animal Practice - Category: Veterinary Research Authors: Source Type: research
This article discusses ethical considerations and principles and propose use of the 4Es model and core communication skills to address ethical dilemmas in veterinary practice. It reviews literature defining ethical issues in practice and provides case examples to show the application of our proposed methods. The goal is to provide veterinary professionals with an approach they can use to frame and address their own ethical decisions.
Source: Veterinary Clinics of North America: Small Animal Practice - Category: Veterinary Research Authors: Source Type: research
One of the most impactful ways to create a dynamic team is to foster diversity and inclusivity within the workplace. Workplaces have become more heterogenous as advances in human, women, and civil rights group have spurred greater labor force participation by members of historically underrepresented groups. Studies have shown that leveraging diversity has important implications for the promotion of positive organization change through facilitation of individual and organization performance. Diverse clientele may be more comfortable and feel more welcome working with people in a diverse workplace.
Source: Veterinary Clinics of North America: Small Animal Practice - Category: Veterinary Research Authors: Source Type: research
The Trevose company was at one time talking with nine interested parties about a deal.
Source: bizjournals.com Health Care:Biotechnology headlines - Category: Biotechnology Authors: Source Type: news
More News: China Health | Drugs & Pharmacology | Investigational New Drugs | Study