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Effect of Weight and/or Obesity on Dapsone Drug Concentrations

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01165840
First Posted: July 20, 2010
Last Update Posted: October 12, 2017
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.
Collaborator:
National Center for Research Resources (NCRR)
Information provided by (Responsible Party):
Ron Hall, Texas Tech University Health Sciences Center
  Purpose
This study will find how weight affects the dosing of a drug called dapsone. Currently, the amount of dapsone a patient receives is the same regardless of the patient's weight.

Condition Intervention Phase
Obesity Leprosy Tuberculosis Drug: Dapsone Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Population Pharmacokinetic Analysis of Dapsone in Normal, Overweight and Obese Volunteers

Resource links provided by NLM:


Further study details as provided by Ron Hall, Texas Tech University Health Sciences Center:

Primary Outcome Measures:
  • Serum Clearance [ Time Frame: 72 hours ]
    Serum clearance of dapsone


Enrollment: 37
Study Start Date: July 2010
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dapsone
Dapsone 100 mg PO x 1 dose
Drug: Dapsone
100 mg PO x 1 dose

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male and female subjects, age >18 years, of all racial and ethnic origins.
  • Non-English speaking Spanish speakers will be included in the study.
  • We are recruiting 12 normal or underweight (BMI <25 kg/m2), 12 overweight or obese (BMI 25-40 kg/m2), and 12 extremely obese (BMI > 40 kg/m2) for this study. This index is calculated using the volunteer's height and weight (Formula: weight (lb) / [height (in)]2 x 703). Half of each group will be male; the other half will be female.

Exclusion Criteria:

  • Pregnant or nursing or unwilling to use a reliable contraception method during the study. The effects of dapsone on pregnancy are unknown. In addition, the metabolic changes that accompany pregnancy may alter the concentration-time profile of dapsone, so that the pregnancy and post-partum state would be a confounding variable.
  • Abnormal liver function tests: transaminases>10 times upper limit of normal, Alkaline phosphatase>5 times upper limit of normal, total bilirubin>5 times upper limit of normal.
  • History of allergies to dapsone, sulfones, or sulfonamides.
  • Dapsone, sulfones, or sulfonamides are contraindicated for any reason.
  • Volunteers unwilling to comply with study procedures.
  • Current suspected or documented infection of any kind.
  • Volunteers with colon resection, gastric bypass, lap band, or any other conditions inhibiting gastric absorption of drug.
  • Current or previous participation within 28 days of enrollment in another research study that involves the use of medication, contrast, or any other compound that may alter blood count and/or blood chemistry (liver function, kidney function or electrolyte balance), unless waved by PI.
  • Donation of 450 milliliters (ml) (one unit) of blood or more within 8 weeks (56 days) prior to study enrollment, unless waved by PI.
  • Current use of zidovudine, amprenavir, rifabutin, rifapentine, or saquinavir.
  • Creatinine clearance < 70 ml/minute (min) as estimated by the Cockcroft-gault equation.
  Contacts and Locations
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): NCT01165840


Locations
United States, Texas
University of Texas Southwestern
Dallas, Texas, United States, 75390
Sponsors and Collaborators
Texas Tech University Health Sciences Center
National Center for Research Resources (NCRR)
Investigators
Principal Investigator: Ronald Hall, PharmD, MSCS Texas Tech UHSC
  More Information

Responsible Party: Ron Hall, Associate Professor, Texas Tech University Health Sciences Center
ClinicalTrials.gov Identifier: NCT01165840     History of Changes
Other Study ID Numbers: AMAIRB97
5UL1RR024982-02 ( U.S. NIH Grant/Contract )
First Submitted: July 16, 2010
First Posted: July 20, 2010
Results First Submitted: October 28, 2015
Results First Posted: July 21, 2016
Last Update Posted: October 12, 2017
Last Verified: June 2016

Keywords provided by Ron Hall, Texas Tech University Health Sciences Center:
Obesity
Pharmacokinetics
Dapsone
Leprosy
Tuberculosis

Additional relevant MeSH terms:
Obesity
Tuberculosis
Leprosy
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Dapsone
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Leprostatic Agents
Anti-Bacterial Agents