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Liposomal Amphotericin B (AmBisome) Pharmacokinetics Given as a Single Intravenous Dose to Obese Patients (ASPEN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02320604
Recruitment Status : Completed
First Posted : December 19, 2014
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
Radboud University

Brief Summary:

Dosing guidelines for liposomal amphotericin B (AmBisome) in (morbidly) obese patients are not available. Subsequently, the pharmacokinetic profile of AmBisome in this specific patient population is still largely unknown.

To build a valid pharmacokinetic model, obese patients with a BMI ≥ 40 undergoing endoscopic gastric bypass surgery will receive a single dose of 1 mg/kg or 2 mg/kg AmBisome (besides standard anti-bacterial prophylaxis) and a PK-curve will be drawn. These PK-values can then be compared to the pharmacokinetics of a normal-weight group.


Condition or disease Intervention/treatment Phase
Morbid Obesity Drug: Administration of study drug Phase 4

Detailed Description:
  • The overall trial design is a prospective, open-label, non-randomized, single-centre, single-dose, multiple dose level trial, (1 mg/kg and 2 mg/kg).
  • A total of sixteen patients with a BMI ≥40 kg/m2 undergoing bariatric surgery who receive a pre-surgery dose of AmBisome 1 mg/kg (n=8) or 2 mg/kg (n=8) will be enrolled.
  • After enrollment of group 1 (1 mg/kg), an interim analysis on the safety of AmBisome will be performed before proceeding to group 2 (2 mg/kg).
  • Infusion time and concentration of AmBisome will be 45 minutes (1 mg/kg group) and 90 minutes (2 mg/kg group)
  • A PK curve will be determined after administration of a single, pre-surgery dose of AmBisome at t = 0.5, 0.75 (end of infusion group 1), 1.5 (end of infusion group 2), 2, 4, 6, 8, 10, 12, 24, 36, and 48 and (if feasible) 72 hours post infusion (n=12 samples) for group 1 (1 mg/kg), 8 patients.The PK curve of group 2 (2 mg/kg, 8 patients) will be similar to group 1, except for the t=1.5 hour sampling point, which will be end of infusion due to the infusion time of 90 minutes.
  • Patients are considered to have completed the study if at least 9/11 samples of the PK curve up until 48 hours have been collected.
  • Patients will be selected by the research team to have a good spread in weight bands.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Pharmacokinetics of Liposomal Amphotericin B (AmBisome®) Given Intravenously to Patients Undergoing Bariatric Surgery
Actual Study Start Date : March 22, 2018
Actual Primary Completion Date : November 3, 2018
Actual Study Completion Date : November 3, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Obese Subjects 1mg/kg
8 obese subjects will receive 1mg/kg Ambisome i.v. infused over 45 minutes
Drug: Administration of study drug
i.v. administration of Ambisome in two different dossages
Other Name: Ambisome

Experimental: Obese Subjects 2mg/kg
8 obese subjects will receive 2mg/kg Ambisome i.v. infused over 90 minutes
Drug: Administration of study drug
i.v. administration of Ambisome in two different dossages
Other Name: Ambisome




Primary Outcome Measures :
  1. Area Under Curve (AUC) 0-inf Ambisome [ Time Frame: at t = 0.5, 0.75, 1.5, 2, 4, 6, 8, 10, 12, 24, 36 and 48 and (if feasible) 72 hours post infusion ]
    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 AmBisome. This will be determined by use of the log-linear trapezoidal rule.


Secondary Outcome Measures :
  1. Peak Plasma Concentration (Cmax) Ambisome [ Time Frame: at t = 0.5, 0.75, 1.5, 2, 4, 6, 8, 10, 12, 24, 36 and 48 and (if feasible) 72 hours post infusion ]
    Peak concentration over the sampling interval.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient has a BMI ≥40 kg/m2 and is undergoing bariatric surgery
  2. Subject is at least 18 of age on the day of screening.
  3. Subject or legal representatives are able and willing to sign the Informed Consent before screening evaluations.

Exclusion Criteria:

  1. Documented history of sensitivity to medicinal products or excipients similar to those found in the polyene preparation.
  2. History of, or current abuse of drugs, alcohol or solvents (up until a maximum of three months before enrolment).
  3. Inability to understand the nature of the trial and the procedures required.
  4. Administration of nephrotoxic medication (aminoglycosids, immunosuppressants, antivirals, antineoplastic agents) up until a maximum of one month before enrolment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02320604


Locations
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Netherlands
Radboud University Medical Center
Nijmegen, Gelderland, Netherlands
St. Antonius hospital
Nieuwegein, Netherlands
Sponsors and Collaborators
Radboud University
Investigators
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Principal Investigator: Roeland E Wasmann, PharmD, PhD Radboud University
Additional Information:
paper  This link exits the ClinicalTrials.gov site

Publications:
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Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT02320604    
Other Study ID Numbers: UMCN-AKF 14.04
First Posted: December 19, 2014    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan has been made. Individual researchers are welcome to request data with our group.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Radboud University:
Liposomal amphotericin B
AmBisome
Pharmacokinetics
Obesity
Bariatric surgery
Additional relevant MeSH terms:
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Obesity, Morbid
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Liposomal amphotericin B
Antifungal Agents
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents