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Effect of Weight and/or Obesity on Dapsone Drug Concentrations

Information source: Texas Tech University Health Sciences Center
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Obesity; Leprosy; Tuberculosis

Intervention: Dapsone (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Texas Tech University Health Sciences Center

Official(s) and/or principal investigator(s):
Ronald Hall, PharmD, MSCS, Principal Investigator, Affiliation: Texas Tech UHSC


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.

Clinical Details

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

Study design: Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Serum Clearance


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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


Locations and Contacts

University of Texas Southwestern, Dallas, Texas 75390, United States
Additional Information

Starting date: July 2010
Last updated: June 9, 2014

Page last updated: August 20, 2015

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