A Pharmacokinetic Study to Compare the Dosing of Valproic Acid in Subjects With Different Body Weights

June 29, 2012 updated by: Northwell Health

An Open-label, Prospective Trial to Determine the Effect(s) of Obesity on the Pharmacokinetic Parameters of Valproic Acid

The purpose of this study is to compare the blood levels of valproic acid in subjects with different body weights and to evaluate whether the pharmacokinetic parameters of this drug is altered in the obese population.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Many pharmacologic agents are dosed based on the weight of the patient, and studies are conducted to determine the appropriate doses of drugs for patients with different weights in order to find the safest and most effective dose for various weights. Valproic acid is a commonly used agent for the treatment of epilepsy, as well as migraine headaches and psychiatric disorders. This prospective study is designed to evaluate the effects of obesity on the pharmacokinetic parameters of valproic acid when compared to individuals at their healthy weight.

Study Type

Interventional

Enrollment

22

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New Hyde Park, New York, United States, 11040
        • Long Island Jewish Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or Female age 21-60 years
  • Normal healthy volunteers as per interview at screening
  • Willing and able to provide written informed consent and comply with the study protocol

Exclusion Criteria:

  • Inability to take oral medications
  • pregnant or lactating females
  • known hypersensitivity to valproic acid
  • BMI less than 18.5 kg/m^2
  • BMI between 25 and 29.9 kg/m^2, inclusive
  • Taking any drug or dietary supplement within one week prior to study period
  • Consumption of food 6 hours prior to study drug ingestion
  • Know family history or history of urea cycle disorders
  • Past history of pancreatitis
  • Past history of liver disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Area under the concentration time curve (AUC) from zero time to the 54-hour blood sampling and clearance in obese verses non-obese subjects after taking valproic acid.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwell Health

Investigators

  • Principal Investigator: Alan Ettinger, MD, North Shore - Long Island Jewish Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Study Completion (ACTUAL)

March 1, 2007

Study Registration Dates

First Submitted

March 2, 2006

First Submitted That Met QC Criteria

March 2, 2006

First Posted (ESTIMATE)

March 3, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

July 3, 2012

Last Update Submitted That Met QC Criteria

June 29, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05.02.045

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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