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

NCT00298857 | Terminated Phase 4

• 1 other identifier: 05.02.045
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy; Obesity; Pharmacokinetics

Keywords

Healthy; Obesity; Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• 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.

Interventions

Valproic acid DRUG

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• Northwell Health: lead

Study Sites (1)

Long Island Jewish Medical Center

New Hyde Park, New York, 11040, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

Valproic Acid

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pentanoic Acids; Valerates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids, Volatile; Fatty Acids; Lipids

Study Officials

• Alan Ettinger, MD

  North Shore - Long Island Jewish Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2006
• First Posted: March 3, 2006
• Study Start: March 1, 2006
• Study Completion: March 1, 2007
• Last Updated: July 3, 2012

Record last verified: 2012-06

Locations

US (1)