A Pharmacokinetic Study to Compare the Dosing of Valproic Acid in Subjects With Different Body Weights
Information source: North Shore Long Island Jewish Health System
Information obtained from ClinicalTrials.gov on March 21, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy; Obesity; Pharmacokinetics
Intervention: Valproic acid (Drug)
Phase: Phase 4
Status: Terminated
Sponsored by: North Shore Long Island Jewish Health System Official(s) and/or principal investigator(s):
Alan Ettinger, MD, Principal Investigator, Affiliation: North Shore - Long Island Jewish Medical Center
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.
Clinical Details
Official title: An Open-Label, Prospective Trial to Determine the Effect(s) of Obesity on the Pharmacokinetic Parameters of Valproic Acid
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study
Primary outcome: 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.
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.
Eligibility
Minimum age: 21 Years.
Maximum age: 60 Years.
Gender(s): Both.
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
Locations and Contacts
Long Island Jewish Medical Center, New Hyde Park, New York 11040, United States
Additional Information
Starting date: March 2006
Last updated: March 23, 2007
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