Effect of Weight and/or Obesity on Dapsone Drug Concentrations

Obesity Clinical Trial

Official title:

Population Pharmacokinetic Analysis of Dapsone in Normal, Overweight and Obese Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01165840
• Other study ID #: AMAIRB97
• Secondary ID: 5UL1RR024982-02
• Status: Completed
• Phase: Phase 4
• First received: July 16, 2010
• Last updated: June 9, 2016
• Start date: July 2010
• Est. completion date: May 2012

Study information

• Verified date: June 2016
• Source: Texas Tech University Health Sciences Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Leprosy
• Obesity
• Tuberculosis

Intervention

Drug:
• Dapsone
100 mg PO x 1 dose

Locations

Country	Name	City	State
United States	University of Texas Southwestern	Dallas	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Texas Tech University Health Sciences Center	National Center for Research Resources (NCRR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum Clearance	Serum clearance of dapsone	72 hours