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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2007-03-31

Brief Summary

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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

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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.

Conditions

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Healthy Obesity Pharmacokinetics

Keywords

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Healthy Obesity Pharmacokinetics

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Valproic acid

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alan Ettinger, MD

Role: PRINCIPAL_INVESTIGATOR

North Shore - Long Island Jewish Medical Center

Locations

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Long Island Jewish Medical Center

New Hyde Park, New York, United States

Site Status

Countries

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United States

Other Identifiers

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05.02.045

Identifier Type: -

Identifier Source: org_study_id