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

Author:

Gelotte Cathy K.,Vakil Amy M.,Berwaerts Joris,Zimmerman Brenda A.,Eichenbaum Gary E.,Flores Christopher M.,Kuffner Edwin K.

Publisher

Elsevier BV

Subject

Toxicology,General Medicine

Reference16 articles.

1. Flores CM, Carson JR, Codd EE, Dax SL, Kuffner EK, Stahle PL, Eichenbaum GE. The Discovery and in Vivo Preclinical Pharmacology of JNJ-10450232 (NTM-006), a Centrally Penetrant, Non-opioid Structural Analog of Acetaminophen with Exhibits Comparable Analgesic and Anti-pyretic Properties but No Evidence of Hepatotoxicity. (this issue).

2. Drug-Induced Liver Injury Network (DILIN) prospective study: rationale, design and conduct;Fontana;Drug Saf.,2009

3. Gelotte CK, Vakil AM, Zimmerman BA, Zannikos P, Mishra R, Eichenbaum GE, Kuffner EK, Flores CM. JNJ-10450232 (NTM-006), A Novel Non-opioid with Structural Similarities to Acetaminophen, Produces Relatively Long-Lasting Analgesia after a Single Dose in Patients Undergoing 3rd Molar Extraction, (this issue).

4. Gelotte CK, Vakil AM, Kuffner EK, Eichenbaum GE, Flores CM, Aquilina J. An Open-Label, 10-day, Multiple-Dose, Safety and Pharmacokinetic Study of a Novel Nonopioid Analgesic, JNJ-10450232, in Healthy Adults (this issue).

5. Lim HK, Chen J, Lam W, Gong Y, Leclercq L, Silva J, Salter R, Berwaerts J, Gelotte CK, Vakil AM, Eichenbaum GE, Kuffner EK, Flores CM. Metabolism and disposition of JNJ-10450232 (NTM-006) in rats, dogs, nonhuman primates and humans. (Regul. Toxicol. Pharmacol., 2022, this issue).

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