Effect of Weight and/or Obesity on Dapsone Drug Concentrations
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ClinicalTrials.gov Identifier: NCT01165840 |
Recruitment Status
:
Completed
First Posted
: July 20, 2010
Results First Posted
: July 21, 2016
Last Update Posted
: July 21, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Obesity Leprosy Tuberculosis | Drug: Dapsone | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 37 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Population Pharmacokinetic Analysis of Dapsone in Normal, Overweight and Obese Volunteers |
Study Start Date : | July 2010 |
Actual Primary Completion Date : | May 2012 |
Actual Study Completion Date : | May 2012 |

Arm | Intervention/treatment |
---|---|
Experimental: Dapsone
Dapsone 100 mg PO x 1 dose
|
Drug: Dapsone
100 mg PO x 1 dose
|
- Serum Clearance [ Time Frame: 72 hours ]Serum clearance of dapsone

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01165840
United States, Texas | |
University of Texas Southwestern | |
Dallas, Texas, United States, 75390 |
Principal Investigator: | Ronald Hall, PharmD, MSCS | Texas Tech UHSC |
Responsible Party: | Ron Hall, Associate Professor, Texas Tech University Health Sciences Center |
ClinicalTrials.gov Identifier: | NCT01165840 History of Changes |
Other Study ID Numbers: |
AMAIRB97 5UL1RR024982-02 ( U.S. NIH Grant/Contract ) |
First Posted: | July 20, 2010 Key Record Dates |
Results First Posted: | July 21, 2016 |
Last Update Posted: | July 21, 2016 |
Last Verified: | June 2016 |
Keywords provided by Ron Hall, Texas Tech University Health Sciences Center:
Obesity Pharmacokinetics Dapsone Leprosy Tuberculosis |
Additional relevant MeSH terms:
Obesity Tuberculosis Leprosy Overnutrition Nutrition Disorders Overweight Body Weight Signs and Symptoms Mycobacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections |
Bacterial Infections Dapsone Anti-Infective Agents Antimalarials Antiprotozoal Agents Antiparasitic Agents Folic Acid Antagonists Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Leprostatic Agents Anti-Bacterial Agents |