Effect of Weight and/or Obesity on Dapsone Drug Concentrations

Study Description

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Brief 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.

Condition or disease	Intervention/treatment	Phase
Obesity; Leprosy; Tuberculosis	Drug: Dapsone	Phase 4

Study Design

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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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Dapsone; Dapsone 100 mg PO x 1 dose	Drug: Dapsone; 100 mg PO x 1 dose

Outcome Measures

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Primary Outcome Measures :

1. Serum Clearance [ Time Frame: 72 hours ]
   Serum clearance of dapsone

Eligibility Criteria

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

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 <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.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Texas
University of Texas Southwestern
Dallas, Texas, United States, 75390

Sponsors and Collaborators

Texas Tech University Health Sciences Center

National Center for Research Resources (NCRR)

Investigators

Principal Investigator:	Ronald Hall, PharmD, MSCS	Texas Tech UHSC

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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