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

Stopped early · Phase 4

Conditions studied: Healthy, Obesity, Pharmacokinetics

In brief

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.

Key facts

Study ID

NCT00298857

Run by

Northwell Health

People needed

22

Starts

2006-03-01

Expected to finish

2007-03-01

Last updated by the study team

2012-07-03

Who can join

Age: 21 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Long Island Jewish Medical Center — New Hyde Park, New York, United States

Full record on ClinicalTrials.gov

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