Pharmacokinetics of liposomal amphotericin B (Ambisome) in obese patients.

Phase 1

• Conditions: Prophylaxis for patients at risk for invasive fungal infection due to gastric bypass surgery.; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]; MedDRA version: 17.1Level: PTClassification code 10017533Term: Fungal infectionSystem Organ Class: 10021881 - Infections and infestations

• Registration Number: EUCTR2014-003306-33-NL
• Lead Sponsor: Radboud university medical center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12-18
• Last Update Posted: 4 December 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

1.Patient has a BMI =40 kg/m2 and is undergoing bariatric surgery.
2.Subject is at least 18 years of age on the day of screening.
3.Subject or legal representatives are able and willing to sign the Informed Consent before screening evaluations.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 14
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2

Exclusion Criteria

1.Documented history of sensitivity to medicinal products or excipients similar to polyene antifungal agents.
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 six months before enrolment.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: •To determine the pharmacokinetics of liposomal amphotericin B administered as a single, intravenous dose (2 mg/kg or 3 mg/kg) to obese patients with a BMI = 40 kg/m2. ;Secondary Objective: •To determine optimal dosing strategy (multiple dose) in obese patients trough Monte Carlo simulations based on the developed PK model. <br>•To compare the PK of liposomal amphotericin B in obese patients to a normal weight reference population. ;Primary end point(s): 1. Determine PK parameters (AUC, Cmax, Cmin, clearance, volume of distribution, half-life, elimination rate constant) after a single intravenous dose.;Timepoint(s) of evaluation of this end point: Day 1, 2 and 3

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): •To determine optimal dosing strategy (multiple dose) in obese patients trough Monte Carlo simulations based on the developed PK model. <br>•To compare the PK of liposomal amphotericin B in obese patients to a normal weight reference population. ;Timepoint(s) of evaluation of this end point: Day 1,2 and 3