Effect of Weight and/or Obesity on Anidulafungin Drug Concentrations

NCT01307930 | Completed Phase 4 Results

• 2 other identifiers: A10-36165UL1RR024982-02
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study will find how weight affects the dosing of a drug called anidulafungin. Currently, the amount of anidulafungin a patient receives is the same regardless of the patient's weight. BMI groups were for enrollment purposes only and not used for ordinal data analysis.

Conditions

Obesity; Mycoses

Keywords

Echinocandin; Obesity; Pharmacokinetics; Pharmacodynamics; Fungal infection

Outcome Measures

Primary Outcomes (1)

• Serum Clearance of Anidulafungin

  How quickly the body eliminates anidulafungin after a single dose

  0-72 hours

Study Arms (1)

Anidulafungin

EXPERIMENTAL

Six volunteers will have a body mass index (BMI) less than 25 kg/m2, 6 will have a BMI 25-40 kg/m2, and 6 will have a BMI greater than 40 kg/m2.

Drug: Anidulafungin

Interventions

Anidulafungin DRUG

Anidulafungin 100 mg IV (each volunteer will only receive one dose of the study drug)

Also known as: Eraxis

Anidulafungin

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 old, of all racial and ethnic origins.
• Non-English-speaking Spanish speakers will be included in the study.
• The investigators are recruiting six normal or underweight (BMI \< 25 kg/m2), six overweight or obese (BMI 25-40 kg/m2), and six 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 anidulafungin on pregnancy are unknown. In addition, the metabolic changes that accompany pregnancy may alter the concentration-time profile of anidulafungin, so that the pregnancy and postpartum state would be a confounding variable.
• Abnormal liver function tests: transaminases \> 3 times upper limit of normal, Alkaline phosphatase \> 3 times upper limit of normal, total bilirubin \> 3 times upper limit of normal.
• History of allergies to echinocandins.
• Echinocandins are contraindicated for any reason.
• Volunteers unwilling to comply with study procedures.
• Suspected or documented systemic fungal infection.
• Concomitant use of rifamycins, tacrolimus, or cyclosporine.
• Current participation 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).
• Creatinine Clearance \< 70 ml/min as estimated by the Cockcroft-Gault equation.

Sponsors & Collaborators

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

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Obesity; Mycoses

Interventions

Anidulafungin

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Echinocandins; Peptides, Cyclic; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Ronald Hall
• Organization: TTUHSC

ronald.hall@ttuhsc.edu

2143589009

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: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 2, 2011
• First Posted: March 3, 2011
• Study Start: January 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: January 9, 2019
• Results First Posted: January 9, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)