Effect of Weight and/or Obesity on Dapsone Drug Concentrations

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2012-05-31

Brief Summary

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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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Detailed Description

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Conditions

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Obesity Leprosy Tuberculosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dapsone

Dapsone 100 mg PO x 1 dose

Group Type EXPERIMENTAL

Dapsone

Intervention Type DRUG

100 mg PO x 1 dose

Interventions

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Dapsone

100 mg PO x 1 dose

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes