Anidulafungin Pharmacokinetics Given as a Single Intravenous Dose to Obese Patients (ADOPT)
Last updated on April 2022Recruitment
- Recruitment Status
- Completed
Inclusion Criteria
- Subject or legal representatives are able and willing to sign the Informed Consent before screening evaluations.
- If subject is female: neither pregnant, nor able to become pregnant and is not nursing an infant.
- Patient has a BMI ≥40 kg/m2 and is undergoing endoscopic gastric bypass surgery.
- ...
- Subject or legal representatives are able and willing to sign the Informed Consent before screening evaluations.
- If subject is female: neither pregnant, nor able to become pregnant and is not nursing an infant.
- 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.
Exclusion Criteria
- History of, or current abuse of drugs, alcohol or solvents.
- Inability to understand the nature of the trial and the procedures required.
- 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.
- Documented history of sensitivity to medicinal products or excipients similar to those found in the echinocandin preparation.
Summary
- Conditions
- Obesity Morbid
- Type
- Interventional
- Phase
- Phase 4
- Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Other
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
All obese patients with a BMI ≥ 40 kg/m2 undergoing endoscopic gastric bypass surgery who receive a prophylactic single dose of 100 mg anidulafungin will be included in the analysis. A PK curve will be determined after administration of anidulafungin at t=0.5, 1, end of infusion, 2, 4, 6, 8, 10, 12,...
All obese patients with a BMI ≥ 40 kg/m2 undergoing endoscopic gastric bypass surgery who receive a prophylactic single dose of 100 mg anidulafungin will be included in the analysis. A PK curve will be determined after administration of anidulafungin at t=0.5, 1, end of infusion, 2, 4, 6, 8, 10, 12, 24, and 48 and (if feasible) 72 hours post infusion (n=12 samples). Blood samples (4 mL) on PK days will be taken to obtain at least 2.0 mL of plasma.
Inclusion Criteria
- Subject or legal representatives are able and willing to sign the Informed Consent before screening evaluations.
- If subject is female: neither pregnant, nor able to become pregnant and is not nursing an infant.
- Patient has a BMI ≥40 kg/m2 and is undergoing endoscopic gastric bypass surgery.
- ...
- Subject or legal representatives are able and willing to sign the Informed Consent before screening evaluations.
- If subject is female: neither pregnant, nor able to become pregnant and is not nursing an infant.
- 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.
Exclusion Criteria
- History of, or current abuse of drugs, alcohol or solvents.
- Inability to understand the nature of the trial and the procedures required.
- 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.
- Documented history of sensitivity to medicinal products or excipients similar to those found in the echinocandin preparation.
Tracking Information
- NCT #
- NCT02021123
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Roger JM Brüggemann, PharmD, PhD Radboud University
- Roger JM Brüggemann, PharmD, PhD Radboud University Medical Center