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Effect of Weight and/or Obesity on Ethambutol Drug Concentrations

Information source: Texas Tech University Health Sciences Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Obesity; Tuberculosis

Intervention: Ethambutol (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Texas Tech University Health Sciences Center

Official(s) and/or principal investigator(s):
Ronald Hall, PharmD, MSCS, Principal Investigator, Affiliation: Texas Tech University HSC

Summary

This study is designed to measure drug concentrations in the blood of healthy volunteers administered a single dose of ethambutol. Our hypothesis is that volunteers with a body mass index (BMI) 25-40 kg/m2 will remove ethambutol more quickly from the blood than leaner volunteers, and those with a BMI > 40 kg/m2 will have even greater clearance than those who are leaner.

Clinical Details

Official title: Population Pharmacokinetics Analysis of Ethambutol in Overweight and Obese Volunteers

Study design: Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Primary outcome: Total Clearance of Ethambutol

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Male and female volunteers, age 18 years of age or older, of all racial and ethnic

origins. English and/or Spanish speaking volunteers are eligible to participate.

- We are recruiting 6 normal weight (BMI <25 kg/m2), 6 obese (BMI 25-40 kg/m2), and 6

extremely obese (BMI > 40 kg/m2) for this study. Half of each group will be male, the other half will be female. Exclusion Criteria:

- Creatinine clearance < 70 ml/min as estimated by the Cockcroft-Gault equation.

- Pregnant or nursing or unwilling to use a reliable contraception method during the

study period. The effects of ethambutol on pregnancy are unknown. In addition, the metabolic changes that accompany pregnancy may alter the concentration-time profile of ethambutol, so that the pregnancy and post-partum state would be a confounding variable.

- Abnormal liver function tests: transaminases >10 time the upper limit of normal,

alkaline phosphatase > 5 time the upper limit of normal, total bilirubin >5 time the upper limit of normal.

- History of allergy to ethambutol.

- Ethambutol is contraindicated for any reason.

- Suspected or documented mycobacterial infection.

- History of gout.

Locations and Contacts

University of Texas Southwestern Medical Center, Dallas, Texas 75390, United States
Additional Information

Starting date: January 2010
Last updated: January 23, 2013

Page last updated: August 23, 2015

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