Clinical trial NCT01165840: Effect of Weight and/or Obesity on Dapsone Drug Concentrations
Official title: Population Pharmacokinetic Analysis of Dapsone in Normal, Overweight and Obese Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Obesity
Leprosy
Tuberculosis
Keywords: Obesity
Pharmacokinetics
Dapsone
Leprosy
Tuberculosis
Lead sponsor: Texas Tech University Health Sciences Center
Sponsor class: OTHER
Collaborators: name: National Center for Research Resources (NCRR)
First posted: 2010-07-20
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Serum Clearance
timeFrame: 72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: University of Texas Southwestern
state: Texas
Study officials:
affiliation: Texas Tech UHSC
name: Ronald Hall, PharmD, MSCS
role: PRINCIPAL_INVESTIGATOR
References: