Effect of Weight and/or Obesity on Dapsone Drug Concentrations
| Status: | Completed |
|---|---|
| Conditions: | Obesity Weight Loss, Infectious Disease |
| Therapuetic Areas: | Endocrinology, Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/14/2017 |
| Start Date: | July 2010 |
| End Date: | May 2012 |
Population Pharmacokinetic Analysis of Dapsone in Normal, Overweight and Obese Volunteers
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.
amount of dapsone a patient receives is the same regardless of the patient's weight.
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.
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