Anidulafungin Pharmacokinetics Given as a Single Intravenous Dose to Obese Patients (ADOPT)

NCT02021123 | Completed Phase 4

• 1 other identifier: UMCN-AKF 13.06
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 2

Brief Summary

Because anidulafungin is generally well tolerated and appears to have limited interaction with other drugs, it is a potential important agent in the treatment of invasive fungal infections. Although anidulafungin is approved for the treatment of invasive candidiasis in adult non-neutropenic patients, dosing guidelines for anidulafungin in (morbidly) obese patients are not available. Subsequently, the pharmacokinetic profile of anidulafungin (as well as other echinocandins) in this specific patient population is still largely unknown. During endoscopic gastric bypass surgery, patients are more prone to various kinds of infection, justifying the prophylactic use of anidulafungin in this specific cohort of patients. To build a valid pharmacokinetic model, obese patients with a BMI ≥ 40 undergoing endoscopic gastric bypass surgery will receive a single dose of 100 mg anidulafungin (besides standard anti-bacterial prophylaxis) and a PK-curve will be drawn. These PK-values can then be compared to the pharmacokinetics in a normal-weight group.

Conditions

Obesity Morbid

Keywords

Anidulafungin; Gastric bypass; Morbidly obese; Pharmacokinetics; Prophylaxis; Yeast infection

Outcome Measures

Primary Outcomes (1)

• anidulafungin area under the curve

  The primary outcome measurement will be the area under the plasma concentration-time curve (AUC) from time 0 to infinitive (inf) post infusion (AUC0- inf) value of anidulafungin. This will be determined by use of the log-linear trapezoidal rule. Peak plasma concentrations (Cmax) will be directly observed from the data. The elimination rate constant will be determined by linear regression of the terminal points of the log-linear plasma concentration time curve. Clearance (CL) will be calculated as dose/AUC0- inf.

  0-72 h after single dose

Secondary Outcomes (1)

• Predict long-term exposure after repeated dosing by using a pharmacokinetic model of anidulafunign in obese patients by using AUC(0-inf), Cmax, elimination half-life and clearance.

  PK curve on day 1-3

Other Outcomes (1)

• adverse events

  0-72 h after dosing

Study Arms (1)

Anidulafungin 100 mg single dose

EXPERIMENTAL

100 mg single dose anidulafungin pre-surgery (gastric bypass)

Drug: Anidulafungin 100mg single dose iv

Interventions

Anidulafungin 100mg single dose iv DRUG

Anidulafungin 100mg single dose iv pre-surgery (gastric bypass)

Also known as: Ecalta

Anidulafungin 100 mg single dose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient has a BMI ≥40 kg/m2 and is undergoing endoscopic gastric bypass surgery.
• Subject is at least 18 years of age on the day of screening.
• If subject is female: neither pregnant, nor able to become pregnant and is not nursing an infant.
• Subject or legal representatives are able and willing to sign the Informed Consent before screening evaluations.

You may not qualify if:

• Documented history of sensitivity to medicinal products or excipients similar to those found in the echinocandin preparation.
• History of, or current abuse of drugs, alcohol or solvents.
• Inability to understand the nature of the trial and the procedures required.

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (2)

Radboud University Medical Center

Nijmegen, Gelderland, Netherlands

Location

St. Antonius hospital

Nieuwegein, Netherlands

Location

Related Publications (1)

• Lempers VJ, van Rongen A, van Dongen EP, van Ramshorst B, Burger DM, Aarnoutse RE, Knibbe CA, Bruggemann RJ. Does Weight Impact Anidulafungin Pharmacokinetics? Clin Pharmacokinet. 2016 Oct;55(10):1289-1294. doi: 10.1007/s40262-016-0401-8.

  PMID: 27142114 RESULT

MeSH Terms

Conditions

Obesity, Morbid

Interventions

Anidulafungin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• Roger JM Brüggemann, PharmD, PhD

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2013
• First Posted: December 27, 2013
• Study Start: August 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: December 1, 2020

Record last verified: 2020-11

Locations

NL (2)