A Study to Evaluate the Safety and Tolerability of Valproic Acid in Healthy Volunteers (Part 1)

NCT01951560 ↗

Phase 1 Completed 59 enrolled Dr. Hasan Alam

RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of the first part of this study is to determine the safety and tolerability of ascending doses of valproic acid (also known as Depacon) administered as intravenous infusion (IV) in doses ranging from 15 mg/kg to 250 mg/kg in healthy subjects. The second part of the study will also be to determine the safety and tolerability of single ascending doses of valproic acid administered as IV in trauma subjects with hemorrhagic shock.

Timeline

Start: 2013-09
Primary completion: 2016-05
Completion: 2016-05

Publications

Georgoff PE, Nikolian VC, Bonham T, Pai MP, Tafatia C, Halaweish I, To K, Watcharotone K, Parameswaran A, Luo R, Sun D, Alam HB. Safety and Tolerability of Intravenous Valproic Acid in Healthy Subjects: A Phase I Dose-Escalation Trial. Clin Pharmacokinet. 2018 Feb;57(2):209-219. doi: 10.1007/s40262-017-0553-1.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Valproic Acid	Small molecule	15 mg/kg	Intravenous
Subject	Valproic Acid	Small molecule	30 mg/kg	Intravenous
Subject	Valproic Acid	Small molecule	60 mg/kg	Intravenous
Subject	Valproic Acid	Small molecule	90 mg/kg	Intravenous
Subject	Valproic Acid	Small molecule	120 mg/kg	Intravenous
Subject	Valproic Acid	Small molecule	150 mg/kg	Intravenous
Subject	Valproic Acid	Small molecule	180 mg/kg	Intravenous
Subject	Valproic Acid	Small molecule	210 mg/kg	Intravenous
Subject	Valproic Acid	Small molecule	250 mg/kg	Intravenous

Indications

No indication recorded.