Overview

Effect of Weight and/or Obesity on Ethambutol Drug Concentrations

Status:
Completed
Trial end date:
2010-12-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Texas Tech University Health Sciences Center
Collaborators:
National Center for Research Resources (NCRR)
University of Texas Southwestern Medical Center
Treatments:
Ethambutol
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.