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

NCT01951560 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2016-12-19

No results posted yet for this study

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.

Conditions

  • Shock,Hemorrhagic

Interventions

DRUG

Valproic Acid

By infusion over 1 hour

DRUG

Isotonic saline solution

By infusion over 1 hour

Sponsors & Collaborators

  • Dr. Hasan Alam

    lead OTHER

Principal Investigators

  • Hasan Alam, MD · University of Michigan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2016-05-31
Completion
2016-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01951560 on ClinicalTrials.gov