A Study to Evaluate the Safety and Tolerability of Valproic Acid in Healthy Volunteers (Part 1)
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|ClinicalTrials.gov Identifier: NCT01951560|
Recruitment Status : Completed
First Posted : September 26, 2013
Last Update Posted : December 19, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Shock,Hemorrhagic||Drug: Valproic Acid Drug: Isotonic saline solution||Phase 1|
Part 1 of the study will be a single center study intended to assess the safety and tolerability of valproic acid dosages at 15 mg/kg, 30 mg/kg, 60 mg/kg, 90 mg/kg, 120 mg/kg, 150 mg/kg 180 mg/kg, 210 mg/kg and 250 mg/kg. Up to 72 healthy subjects (9 dose groups of 8 subjects) will receive single doses of valproic acid or placebo via a 60-min IV infusion in a ratio of 3:1 active drug: placebo.
Part 2 of the study will be a multicenter, double blind, placebo-controlled study in trauma patients with hemorrhagic shock who are able to give consent or severe trauma patients with hemorrhagic shock in whom a legally authorized representative can give consent. Up to 12 patients (2 dose groups of 6 patients) will receive single doses of valproic acid or placebo via a 60-min IV infusion in a ratio of 2:1 active drug : placebo. The dose levels in Part 2 will be the two highest doses that are demonstrated to have acceptable safety profile based on the review of safety data from Part 1.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||59 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A Phase 1, Single Ascending Dose, Double Blind, Placebo Controlled Study to Evaluate the Safety and Tolerability of Valproic Acid in Healthy Volunteers (Part 1) or Trauma Patients(Part 2)|
|Study Start Date :||September 2013|
|Actual Primary Completion Date :||May 2016|
|Actual Study Completion Date :||May 2016|
Experimental: valproic acid (Depacon)
Valproic acid by IV infusion over one hour
Drug: Valproic Acid
By infusion over 1 hour
Other Name: Depacon
Placebo Comparator: Isotonic saline solution
The placebo administered by IV infusion over 1 hour
Drug: Isotonic saline solution
By infusion over 1 hour
- Dose limiting toxicity (DLT) [ Time Frame: Subjects will be monitored for 4 days after the one hour infusion. Dose escalation may occur if less than 2 subjects in any cohort of 8 experience DLT. ]Dose limiting toxicity (DLT) will be defined as drug-related grade 2 (moderate) or higher toxicity (excluding fever, chills, nausea or other possible infusion-related effects). The maximum tolerated dose (MTD) will be declared at the dose below which 2 or more subjects experience DLT.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01951560
|United States, Michigan|
|The University of Michigan|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||Hasan Alam, MD||University of Michigan|