Liposomal Amphotericin B (AmBisome) Pharmacokinetics Given as a Single Intravenous Dose to Obese Patients (ASPEN)
Ключови думи
Резюме
Описание
- 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.
Дати
| Последна проверка: | 12/31/2018 |
| Първо изпратено: | 10/30/2014 |
| Очаквано записване подадено: | 12/14/2014 |
| Първо публикувано: | 12/18/2014 |
| Изпратена последна актуализация: | 01/20/2019 |
| Последна актуализация публикувана: | 01/22/2019 |
| Действителна начална дата на проучването: | 03/21/2018 |
| Приблизителна дата на първично завършване: | 11/02/2018 |
| Очаквана дата на завършване на проучването: | 11/02/2018 |
Състояние или заболяване
Интервенция / лечение
Drug: Administration of study drug
Фаза
Групи за ръце
| Arm | Интервенция / лечение |
|---|---|
| Experimental: Obese Subjects 1mg/kg 8 obese subjects will receive 1mg/kg Ambisome i.v. infused over 45 minutes | |
| Experimental: Obese Subjects 2mg/kg 8 obese subjects will receive 2mg/kg Ambisome i.v. infused over 90 minutes |
Критерии за допустимост
| Възрасти, отговарящи на условията за проучване | 18 Years Да се 18 Years |
| Полове, допустими за проучване | All |
| Приема здрави доброволци | Да |
| Критерии | 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. |
Резултат
Първични изходни мерки
1. Area Under Curve (AUC) 0-inf Ambisome [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]
Вторични изходни мерки
1. Peak Plasma Concentration (Cmax) Ambisome [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]
