Effect of Weight and/or Obesity on Dapsone Drug Concentrations

Texas Tech University Health Sciences Center

Status and phase

Completed

Phase 4

Conditions

Tuberculosis

Obesity

Leprosy

Treatments

Drug: Dapsone

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT01165840

5UL1RR024982-02 (U.S. NIH Grant/Contract)

AMAIRB97

Details and patient eligibility

About

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.

Enrollment

37 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.