Background And Objectives: Daridorexant, a dual orexin receptor antagonist was recently approved for the treatment of insomnia at doses up to 50 mg once per night. This study investigated the effect of single-dose and multiple-dose daridorexant 50 mg at steady state on the pharmacokinetics (PK) of the cytochrome P450 (CYP) 3A4-sensitive substrate midazolam, and the effect of single-dose daridorexant 50 mg on the PK and pharmacodynamics (PD) of the CYP2C9-sensitive substrate warfarin.
Methods: In this prospective, single-center, open-label, fixed-sequence, phase I, drug-drug interaction study, 18 healthy male subjects sequentially received Treatment A, B, and C in three periods.
Background: Per- and polyfluoroalkyl substances (PFAS) are environmental contaminants that have received significant public attention. PFAS are a large group of human-made chemicals that have been used in industry and consumer products worldwide since the 1950s. Human exposure to PFAS is a growing public health concern.
View Article and Find Full Text PDFThis study evaluated the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple oral doses of enpatoran (formerly named M5049), a new toll-like receptor (TLR) 7 and 8 dual antagonist, and the effect of food on a single dose in healthy participants. In this single phase 1, randomized (3:1), double-blind, placebo-controlled study, 96 participants received single and multiple ascending oral doses of enpatoran. Participants in single-dose cohorts received one dose of enpatoran (1, 3, 9, 25, 50, 100, or 200 mg) or placebo using a sentinel dosing strategy.
View Article and Find Full Text PDFJ Expo Sci Environ Epidemiol
November 2021
The National Center for Environmental Health (NCEH), part of the Centers for Disease Control and Prevention (CDC), and the Agency for Toxic Substances and Disease Registry (ATSDR) support and conduct research advancing national, state, and local public health response to per- and polyfluoroalkyl substances (PFAS). PFAS are a group of manufactured chemicals used in industry and consumer products that persist in the environment. Given the growing evidence linking PFAS with adverse health effects in humans, NCEH and ATSDR developed a public health research framework to capture the broad range of PFAS research activities being conducted and supported by the agency to determine future research priorities and identify opportunities for interagency collaboration.
View Article and Find Full Text PDF