Effect of Weight and/or Obesity on Dapsone Drug Concentrations
This study has been completed.
Sponsor:
Texas Tech University Health Sciences Center
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: December 13, 2012
Last verified: December 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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: | 36 |
| 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 |
| 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 450mL (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/min as estimated by the Cockcroft-gault equation.
Contacts and Locations
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
Investigators
| Principal Investigator: | Ronald Hall, PharmD, MSCS | Texas Tech UHSC |
More Information
No publications provided
| Responsible Party: | Ron Hall, Associate Professor, Texas Tech University Health Sciences Center |
| ClinicalTrials.gov Identifier: | NCT01165840 History of Changes |
| Other Study ID Numbers: | AMAIRB97, 5UL1RR024982-02 |
| Study First Received: | July 16, 2010 |
| Last Updated: | December 13, 2012 |
| 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:
|
Leprosy Obesity Tuberculosis Mycobacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections Overnutrition Nutrition Disorders Overweight Body Weight Signs and Symptoms |
Dapsone Antimalarials Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Folic Acid Antagonists Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Leprostatic Agents Anti-Bacterial Agents |
ClinicalTrials.gov processed this record on May 22, 2013