Phase 4
Completed N=36
Effect of Weight and/or Obesity on Dapsone Drug Concentrations
Obesity · Leprosy · Tuberculosis
Source: ClinicalTrials.gov NCT01165840 ↗
Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Jul 2016
Primary outcomePrimary: Serum Clearance — 2.55 L/h
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Serum Clearance |
2.55 | — |
Eligibility 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 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.
Data sourced from ClinicalTrials.gov (NCT01165840). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.