Human Safety, Tolerability, and Pharmacokinetics of Molnupiravir, a Novel Broad-Spectrum Oral Antiviral Agent with Activity against SARS-CoV-2

Author:

Painter Wendy P.1ORCID,Holman Wayne1,Bush Jim A.2,Almazedi Firas2,Malik Hamzah2,Eraut Nicola C. J. E.2,Morin Merribeth J.1,Szewczyk Laura J.1,Painter George R.3

Affiliation:

1. Ridgeback Biotherapeutics LP, Miami, Florida, USA

2. Covance Clinical Research Unit Limited, Leeds, United Kingdom

3. Department of Pharmacology and Chemical Biology, Emory University School of Medicine, Atlanta, Georgia, USA

Abstract

Molnupiravir (EIDD-2801/MK-4482), the prodrug of the active antiviral ribonucleoside analog β- d -N4-hydroxycytidine (NHC; EIDD-1931), has activity against a number of RNA viruses, including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), severe acute respiratory syndrome coronavirus (SARS-CoV), Middle East respiratory syndrome coronavirus (MERS-CoV), and seasonal and pandemic influenza viruses. Single and multiple doses of molnupiravir were evaluated in this first-in-human, phase 1, randomized, double-blind, placebo-controlled study in healthy volunteers, which included evaluation of the effect of food on pharmacokinetics.

Publisher

American Society for Microbiology

Subject

Infectious Diseases,Pharmacology (medical),Pharmacology

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