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Effect of Weight and/or Obesity on Dapsone Drug Concentrations

Primary Purpose

Obesity, Leprosy, Tuberculosis

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Dapsone

About this trial

This is an interventional treatment trial for Obesity focused on measuring Obesity, Pharmacokinetics, Dapsone, Leprosy, Tuberculosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

University of Texas Southwestern

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dapsone

Arm Description

Dapsone 100 mg PO x 1 dose

Outcomes

Primary Outcome Measures

Serum Clearance

Serum clearance of dapsone

Secondary Outcome Measures

Full Information

NCT ID

NCT01165840

First Posted

July 16, 2010

Last Updated

June 9, 2016

Sponsor

Texas Tech University Health Sciences Center

Collaborators

National Center for Research Resources (NCRR)

1. Study Identification

Unique Protocol Identification Number

NCT01165840

Brief Title

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

2. Study Status

Record Verification Date

June 2016

Overall Recruitment Status

Completed

Study Start Date

July 2010 (undefined)

Primary Completion Date

May 2012 (Actual)

Study Completion Date

May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Texas Tech University Health Sciences Center

Collaborators

National Center for Research Resources (NCRR)

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity, Leprosy, Tuberculosis

Keywords

Obesity, Pharmacokinetics, Dapsone, Leprosy, Tuberculosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

37 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dapsone

Arm Type

Experimental

Arm Description

Dapsone 100 mg PO x 1 dose

Intervention Type

Drug

Intervention Name(s)

Dapsone

Intervention Description

100 mg PO x 1 dose

Primary Outcome Measure Information:

Title

Serum Clearance

Description

Serum clearance of dapsone

Time Frame

72 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ronald Hall, PharmD, MSCS

Organizational Affiliation

Texas Tech UHSC

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Texas Southwestern

City

Dallas

State/Province

Texas

ZIP/Postal Code

75390

Country

United States

12. IPD Sharing Statement

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Effect of Weight and/or Obesity on Dapsone Drug Concentrations

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