Effect of Weight and/or Obesity on Dapsone Drug Concentrations
This study has been completed.
Sponsor:
Texas Tech University Health Sciences Center
Collaborator:
National Center for Research Resources (NCRR)
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, 2016
Last verified: June 2016
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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: | 37 |
| 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 (Adult, Senior) |
| 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 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.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01165840
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
National Center for Research Resources (NCRR)
Investigators
| Principal Investigator: | Ronald Hall, PharmD, MSCS | Texas Tech UHSC |
More Information
| Responsible Party: | Ron Hall, Associate Professor, Texas Tech University Health Sciences Center |
| ClinicalTrials.gov Identifier: | NCT01165840 History of Changes |
| Obsolete Identifiers: | NCT01307930 |
| Other Study ID Numbers: | AMAIRB97 5UL1RR024982-02 |
| Study First Received: | July 16, 2010 |
| Results First Received: | October 28, 2015 |
| Last Updated: | June 9, 2016 |
| 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:
|
Obesity Tuberculosis Leprosy Overnutrition Nutrition Disorders Overweight Body Weight Signs and Symptoms Mycobacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections |
Bacterial Infections Dapsone Anti-Infective Agents Antimalarials Antiprotozoal Agents Antiparasitic Agents Folic Acid Antagonists Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Leprostatic Agents Anti-Bacterial Agents |
ClinicalTrials.gov processed this record on September 28, 2016