Effect of Weight and/or Obesity on Dapsone Drug Concentrations

NCT01165840 | Completed Phase 4 Results

• 2 other identifiers: AMAIRB975UL1RR024982-02
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Leprosy; Tuberculosis

Keywords

Obesity; Pharmacokinetics; Dapsone; Leprosy; Tuberculosis

Outcome Measures

Primary Outcomes (1)

• Serum Clearance

  Serum clearance of dapsone

  72 hours

Study Arms (1)

Dapsone

EXPERIMENTAL

Dapsone 100 mg PO x 1 dose

Drug: Dapsone

Interventions

Dapsone DRUG

100 mg PO x 1 dose

Dapsone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Texas Tech University Health Sciences Center: lead
• National Center for Research Resources (NCRR): collaborator

Study Sites (1)

University of Texas Southwestern

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Obesity; Leprosy; Tuberculosis

Interventions

Dapsone

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mycobacterium Infections, Nontuberculous; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Sulfones; Sulfur Compounds; Organic Chemicals

Results Point of Contact

• Title: Ronald Hall
• Organization: Texas Tech University HSC

ronald.hall@ttuhsc.edu

214-358-9009

Study Officials

• Ronald Hall, PharmD, MSCS

  Texas Tech UHSC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 16, 2010
• First Posted: July 20, 2010
• Study Start: July 1, 2010
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: July 21, 2016
• Results First Posted: July 21, 2016

Record last verified: 2016-06

Locations

US (1)