First-in-human study to evaluate the safety, tolerability and pharmacokinetics of a novel analgesic and antipyretic drug with structural similarity to acetaminophen

Autor:	Cathy K. Gelotte, Amy M. Vakil, Joris Berwaerts, Brenda A. Zimmerman, Gary E. Eichenbaum, Christopher M. Flores, Edwin K. Kuffner
Rok vydání:	2021
Předmět:	Male Analgesics Antipyretics Dose-Response Relationship Drug Double-Blind Method Area Under Curve Humans General Medicine Toxicology Acetaminophen
Zdroj:	Regulatory toxicology and pharmacology : RTP. 134
ISSN:	1096-0295
Popis:	JNJ-10450232 (NTM-006) is a new molecular entity that comprises structural similarities to acetaminophen and provides comparable analgesia in animals and humans without causing the hepatotoxicity associated with acetaminophen overdose in preclinical models. This double-blind, placebo-controlled, first-in-human study evaluated the safety, tolerability, and pharmacokinetics of JNJ-10450232 (NTM-006) following single (50-6000 mg) and multiple (250-2500 mg twice daily for 8 days) doses in healthy male volunteers. JNJ-10450232 (NTM-006) was absorbed within 1-3 h, except at high doses at which C
Databáze:	OpenAIRE
Externí odkaz:	https://explore.openaire.eu/search/publication?articleId=doi_dedup___::4cd2b3bcfd9add9f3d693dd2ac4823cb https://pubmed.ncbi.nlm.nih.gov/35934140 Zobrazit plný text záznamu Full Text from ScienceDirect