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

This study has been terminated.
(Lack of funding)
Sponsor:
Information provided by (Responsible Party):
North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier:
NCT00298857
First received: March 2, 2006
Last updated: June 29, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Healthy
Obesity
Pharmacokinetics
Drug: Valproic acid
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label, Prospective Trial to Determine the Effect(s) of Obesity on the Pharmacokinetic Parameters of Valproic Acid

Resource links provided by NLM:


Further study details as provided by North Shore Long Island Jewish Health System:

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.

Estimated Enrollment: 22
Study Start Date: March 2006
Study Completion Date: March 2007
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

Ages Eligible for Study:   21 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00298857

Locations
United States, New York
Long Island Jewish Medical Center
New Hyde Park, New York, United States, 11040
Sponsors and Collaborators
North Shore Long Island Jewish Health System
Investigators
Principal Investigator: Alan Ettinger, MD North Shore - Long Island Jewish Medical Center
  More Information

No publications provided

Responsible Party: North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier: NCT00298857     History of Changes
Other Study ID Numbers: 05.02.045
Study First Received: March 2, 2006
Last Updated: June 29, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by North Shore Long Island Jewish Health System:
Healthy
Obesity
Pharmacokinetics

Additional relevant MeSH terms:
Obesity
Body Weight
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms
Valproic Acid
Anticonvulsants
Antimanic Agents
Central Nervous System Agents
Central Nervous System Depressants
Enzyme Inhibitors
GABA Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on October 23, 2014