Safety and Tolerability of Intravenous Valproic Acid in Healthy Subjects: A Phase I Dose-Escalation Trial

• Published in: Clinical pharmacokinetics Vol. 57; no. 2; pp. 209 - 219
• Main Authors: Georgoff, Patrick E., Nikolian, Vahagn C., Bonham, Tess, Pai, Manjunath P., Tafatia, Celia, Halaweish, Ihab, To, Kathleen, Watcharotone, Kuanwong, Parameswaran, Aishwarya, Luo, Ruijuan, Sun, Duxin, Alam, Hasan B.
• Format: Journal Article
• Language: English
• Published: Cham Springer International Publishing 01.02.2018; Springer Nature B.V
• Subjects: Acids; Administration, Intravenous; Adolescent; Adult; Alcohol; Blood & organ donations; Cancer; Chromatin; Dose-Response Relationship, Drug; Double-Blind Method; Drug dosages; Family medical history; FDA approval; Female; Gene expression; Hemorrhage; Hemorrhagic shock; Histone Deacetylase Inhibitors - administration & dosage; Histone Deacetylase Inhibitors - adverse effects; Humans; Internal Medicine; Kinases; Male; Maximum Tolerated Dose; Medicine; Medicine & Public Health; Middle Aged; Models, Biological; Mortality; NCT; NCT01951560; Original Research Article; Pharmacology/Toxicology; Pharmacotherapy; Prescription drugs; Sepsis; Studies; Substance abuse treatment; Trauma; Traumatic brain injury; Valproic Acid - administration & dosage; Valproic Acid - adverse effects; Young Adult; United States > US

Background Valproic acid, a histone deacetylase inhibitor, has beneficial effects in the setting of cancer, neurologic diseases, and traumatic injuries. In animal models of traumatic injury, a single dose of valproic acid has been shown to reduce mortality. The purpose of this trial was to determine...