Back to resultsA Pharmacokinetic Study to Compare the Dosing of Valproic Acid in Subjects With Different Body Weights
Primary Purpose
Healthy, Obesity, Pharmacokinetics
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Valproic acid
Sponsored by
About this trial
This is an interventional treatment trial for Healthy focused on measuring Healthy, Obesity, Pharmacokinetics
Eligibility Criteria
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
Sites / Locations
- Long Island Jewish Medical Center
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00298857
Brief Title
A Pharmacokinetic Study to Compare the Dosing of Valproic Acid in Subjects With Different Body Weights
Official Title
An Open-label, Prospective Trial to Determine the Effect(s) of Obesity on the Pharmacokinetic Parameters of Valproic Acid
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Terminated
Why Stopped
Lack of funding
Study Start Date
March 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Northwell Health
4. Oversight
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Obesity, Pharmacokinetics
Keywords
Healthy, Obesity, Pharmacokinetics
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
22 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Valproic acid
Primary Outcome Measure Information:
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alan Ettinger, MD
Organizational Affiliation
North Shore - Long Island Jewish Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Long Island Jewish Medical Center
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Pharmacokinetic Study to Compare the Dosing of Valproic Acid in Subjects With Different Body Weights
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