Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of Weight and/or Obesity on Ethambutol Drug Concentrations

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01048697
Recruitment Status : Completed
First Posted : January 14, 2010
Results First Posted : January 24, 2013
Last Update Posted : January 24, 2013
Sponsor:
Collaborators:
National Center for Research Resources (NCRR)
University of Texas Southwestern Medical Center
Information provided by (Responsible Party):
Ron Hall, Texas Tech University Health Sciences Center

Brief 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.

Condition or disease Intervention/treatment Phase
Obesity Tuberculosis Drug: Ethambutol Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Population Pharmacokinetics Analysis of Ethambutol in Overweight and Obese Volunteers
Study Start Date : January 2010
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ethambutol

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)

Drug: Ethambutol

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)

Other Name: Myambutol




Primary Outcome Measures :
  1. Total Clearance of Ethambutol [ Time Frame: Blood samples will be collected over a 24 hour period (0, 2, 6, 11, 18, and 24 hours) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01048697


Locations
Layout table for location information
United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Sponsors and Collaborators
Texas Tech University Health Sciences Center
National Center for Research Resources (NCRR)
University of Texas Southwestern Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Ronald Hall, PharmD, MSCS Texas Tech University HSC
Publications of Results:
Layout table for additonal information
Responsible Party: Ron Hall, Associate Professor, Texas Tech University Health Sciences Center
ClinicalTrials.gov Identifier: NCT01048697    
Other Study ID Numbers: TTUHSC 030032
5UL1RR024982-02 ( U.S. NIH Grant/Contract )
First Posted: January 14, 2010    Key Record Dates
Results First Posted: January 24, 2013
Last Update Posted: January 24, 2013
Last Verified: January 2013
Keywords provided by Ron Hall, Texas Tech University Health Sciences Center:
Obesity
Pharmacokinetics
Pharmacodynamics
Dose individualization
Tuberculosis
Additional relevant MeSH terms:
Layout table for MeSH terms
Tuberculosis
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Ethambutol
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents