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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00298857
• Other study ID #: 05.02.045
• Status: Terminated
• Phase: Phase 4
• First received: March 2, 2006
• Last updated: June 29, 2012
• Start date: March 2006
• Est. completion date: March 2007

Study information

• Verified date: June 2012
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 22
• Est. completion date: March 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 60 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy
• Obesity
• Pharmacokinetics

Intervention

Drug:
• Valproic acid

Locations

Country	Name	City	State
United States	Long Island Jewish Medical Center	New Hyde Park	New York

Sponsors (1)

Lead Sponsor	Collaborator
Northwell Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.