Phase 4
N=18
Effect of Weight and/or Obesity on Ethambutol Drug Concentrations
Obesity · Tuberculosis
Bottom Line
View on ClinicalTrials.gov: NCT01048697 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Jan 2013
Primary outcome: Primary: Total Clearance of Ethambutol — 80.8 L/h
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Ethambutol (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Texas Tech University Health Sciences Center
- Primary completion
- Dec 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Clearance of Ethambutol |
80.8 | — |
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.
Eligibility 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 40 kg/m2) for this study. Half of each group will be male, the other half will be female.
Exclusion Criteria
- Creatinine clearance 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.
Data sourced from ClinicalTrials.gov (NCT01048697). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.