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Effect of Weight and/or Obesity on Dapsone Drug Concentrations

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ClinicalTrials.gov Identifier: NCT01165840
Recruitment Status : Completed
First Posted : July 20, 2010
Results First Posted : July 21, 2016
Last Update Posted : July 21, 2016
Sponsor:
Collaborator:
National Center for Research Resources (NCRR)
Information provided by (Responsible Party):
Ron Hall, Texas Tech University Health Sciences Center

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Obesity Leprosy Tuberculosis Drug: Dapsone Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: N/A
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
Study Start Date : July 2010
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Leprosy
Drug Information available for: Dapsone

Arms and Interventions
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Arm Intervention/treatment
Experimental: Dapsone
Dapsone 100 mg PO x 1 dose
 Drug: Dapsone
100 mg PO x 1 dose


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


Eligibility Criteria
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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 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
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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
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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
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Principal Investigator: Ronald Hall, PharmD, MSCS Texas Tech UHSC
More Information
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Responsible Party: Ron Hall, Associate Professor, Texas Tech University Health Sciences Center
ClinicalTrials.gov Identifier: NCT01165840    
Other Study ID Numbers: AMAIRB97
5UL1RR024982-02 ( U.S. NIH Grant/Contract )
First Posted: July 20, 2010    Key Record Dates
Results First Posted: July 21, 2016
Last Update Posted: July 21, 2016
Last Verified: June 2016
Keywords provided by Ron Hall, Texas Tech University Health Sciences Center:
Obesity
Pharmacokinetics
Dapsone
Leprosy
Tuberculosis
Additional relevant MeSH terms:
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Tuberculosis
Leprosy
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
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