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Completed

NCT Number: NCT01165840

Effect of Weight and/or Obesity on Dapsone Drug Concentrations

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.

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Key information

Conditions

Obesity Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Body Weight Gram-Positive Bacterial Infections Infections Leprosy Mycobacterium Infections Mycobacterium Infections, Nontuberculous Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Tuberculosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Texas Southwestern

Dallas, Texas, 75390, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dapsone

Drug

100 mg PO x 1 dose

Primary outcomes

  1. Serum Clearance

    Time frame: 72 hours

    Serum clearance of dapsone

Sponsors and collaborators

Lead sponsor

Texas Tech University Health Sciences Center

Other

Collaborators

  • National Center for Research Resources (NCRR)

Registry information

Official study title

Population Pharmacokinetic Analysis of Dapsone in Normal, Overweight and Obese Volunteers

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jul 20, 2010
Registry last updated
Jul 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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