CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 18 enrolled
Drug / intervention
Ethambutoldrug
Likely dose
Ethambutol 800 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01048697
NCT01048697Phase 4Completed
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Population Pharmacokinetics Analysis of Ethambutol in Overweight and Obese Volunteers

Texas Tech University Health Sciences Center·interventional·Posted Jan 14, 2010·Updated Jan 24, 2013

In Brief

A Phase 4 clinical trial evaluating Ethambutol for Obesity and Tuberculosis. Completed, enrolled 18 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObesity, Tuberculosis
CountriesUnited States
CollaboratorsNational Center for Research Resources (NCRR), University of Texas Southwestern Medical Center

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 14, 2010
Enrollment StartJan 1, 2010
Primary CompletionDec 1, 2010
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 16.5 years ago

Interventions

Ethambutoldrug

All volunteers in each category will receive a single dose of oral ethambutol based on American Thoracic Society/Centers for Disease Control and Prevention/Infectious Diseases Society of American (ATS/CDC/IDSA) TB treatment guidelines.1 We will not use any doses higher than the maximum dose recommended for daily administration by the current ATS/CDC/IDSA TB guidelines (which use ideal body weight for dosing): 40-55kg: 800 mg (two 400 mg tablets) 56-75kg: 1,200 mg (three 400 mg tablets) 76-90kg: 1,600 mg (four 400 mg tablets) \> 90 kg: No dosage recommendations so these volunteers will only receive 1,600 mg (four 400 mg tablets)