Leprosy, Obesity, Tuberculosis
Conditions
Keywords
Obesity, Pharmacokinetics, Dapsone, Leprosy, Tuberculosis
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.
Interventions
DRUGDapsone
100 mg PO x 1 dose
Sponsors
National Center for Research Resources (NCRR)
Texas Tech University Health Sciences Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum Clearance | 72 hours | Serum clearance of dapsone |
Countries
United States
Participant flow
Recruitment details
Patients were recruited into three BMI groups to ensure a wide total body weight distribution, but only one pharmacokinetic model was analyzed with total body weight being one of the potential covariates that was assessed.
Pre-assignment details
Thirty-seven patient provided consent, but only 36 started the study. One patient provided informed consent but was found to have G6PD and was not allowed to continue.
Participants by arm
| Arm | Count |
|---|---|
| Dapsone Dapsone 100 mg PO x 1 dose
Dapsone: 100 mg PO x 1 dose | 36 |
| Total | 36 |
Baseline characteristics
| Characteristic | Dapsone |
|---|---|
| Age, Categorical <=18 years | 1 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 34 Participants |
| Age, Continuous | 38.2 years STANDARD_DEVIATION 13.7 |
| Region of Enrollment United States | 36 participants |
| Sex: Female, Male Female | 18 Participants |
| Sex: Female, Male Male | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 36 |
| serious Total, serious adverse events | 0 / 36 |
Outcome results
Primary
Serum Clearance
Serum clearance of dapsone
Time frame: 72 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dapsone | Serum Clearance | 2.55 L/h | Standard Deviation 1.24 |