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

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

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00298857

Enrollment

Registered

2006-03-03

Start date

2006-03-31

Completion date

2007-03-31

Last updated

2012-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy, Obesity, Pharmacokinetics

Keywords

Healthy, Obesity, Pharmacokinetics

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.

Interventions

DRUGValproic acid

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

21 Years to 60 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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.	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026