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: June 9, 2014
Last verified: June 2014

July 16, 2010
June 9, 2014
July 2010
May 2012   (final data collection date for primary outcome measure)
Serum Clearance [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
Serum clearance of dapsone
Same as current
Complete list of historical versions of study NCT01165840 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Effect of Weight and/or Obesity on Dapsone Drug Concentrations
Population Pharmacokinetic Analysis of Dapsone in Normal, Overweight and Obese Volunteers

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.

Not Provided
Interventional
Phase 4
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Obesity
  • Leprosy
  • Tuberculosis
Drug: Dapsone
100 mg PO x 1 dose
Experimental: Dapsone
Dapsone 100 mg PO x 1 dose
Intervention: Drug: Dapsone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
37
May 2012
May 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01165840
AMAIRB97, 5UL1RR024982-02
No
Ron Hall, Texas Tech University Health Sciences Center
Texas Tech University Health Sciences Center
National Center for Research Resources (NCRR)
Principal Investigator: Ronald Hall, PharmD, MSCS Texas Tech UHSC
Texas Tech University Health Sciences Center
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP