Effect of Weight and/or Obesity on Dapsone Drug Concentrations

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Ron Hall, Texas Tech University Health Sciences Center
ClinicalTrials.gov Identifier:
NCT01165840
First received: July 16, 2010
Last updated: December 13, 2012
Last verified: December 2012
  Purpose

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 Intervention Phase
Obesity
Leprosy
Tuberculosis
Drug: Dapsone
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Population Pharmacokinetic Analysis of Dapsone in Normal, Overweight and Obese Volunteers

Resource links provided by NLM:


Further study details as provided by Texas Tech University Health Sciences Center:

Primary Outcome Measures:
  • Serum Clearance [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
    Serum clearance of dapsone


Enrollment: 36
Study Start Date: July 2010
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dapsone
Dapsone 100 mg PO x 1 dose
Drug: Dapsone
100 mg PO x 1 dose

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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 450mL (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/min as estimated by the Cockcroft-gault equation.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01165840

Locations
United States, Texas
University of Texas Southwestern
Dallas, Texas, United States, 75390
Sponsors and Collaborators
Texas Tech University Health Sciences Center
Investigators
Principal Investigator: Ronald Hall, PharmD, MSCS Texas Tech UHSC
  More Information

No publications provided

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
Study First Received: July 16, 2010
Last Updated: December 13, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Texas Tech University Health Sciences Center:
Obesity
Pharmacokinetics
Dapsone
Leprosy
Tuberculosis

Additional relevant MeSH terms:
Leprosy
Obesity
Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Dapsone
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Leprostatic Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on April 20, 2014