Clinical trial NCT05749380: Pharmacokinetics and Safety of AmBisome and DKF-5122
Official title: Bioequivalence Study to Evaluate Pharmacokinetics and Safety of AmBisome and DKF-5122 in Indicated Patients and Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Invasive Fungal Infections
Neutropenic Fever
Lead sponsor: Dongkook Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-03-01
Enrollment: 38
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The purpose of the study is to assess the Safety and Pharmacokinetic Characteristics of AmBisome and DKF-5122


Eligibility criteria: Inclusion Criteria:

* Part 1. Patients

  1. Age 19 years and older
  2. Empirical therapy for presumed fungal infection in febrile, neutropenic patients
  3. Voluntarily decided to participate in the study and signed the informed consent form
  4. Having contraception during the study
* Part 2. Healthy subjects

  1. Age 19 to 45 years
  2. Body weight 55 kg or more, within ±20% of the ideal body weight
  3. Having no congenital or chronic disease within the last 5 years.
  4. Voluntarily decided to participate in the study and signed the informed consent form
  5. Having contraception during the study

Exclusion Criteria:

* Part 1. Patients

  1. Clinically significant conditions that may affect the pharmacokinetics of amphotericin
  2. History of diseases that may affect the pharmacokinetics of amphotericin
  3. History of drug abuse
  4. History of hypersensitivity to ingredients of investigational products
  5. Unable to maintain proper contraception
  6. Pregnant or breast-feeding
  7. The following laboratory test results at screening

     * Hemoglobin \< 8.0 g/dL
     * Serum Creatinine \> 2x the UNL
     * AST or ALT \> 10x UNL
     * Systolic blood pressure ≥ 140 mmHg or ≤ 90 mmHg
     * Diastolic blood pressure ≥ 90 mmHg or ≤ 60 mmHg
  8. Before the first administration of investigational products

     * Participation to other clinical trials within 6 months
     * Whole blood donation within 60 days or component within 30 days
     * (Herbal) medicines that may affect the pharmacokinetics of amphotericin within 14 days
     * Grapefruit-containing foods within 7 days
     * Excessive exercise within 7 days
  9. Excessive caffeine and alcohol consumption, or a smoker
  10. Not eligible due to other reasons at the investigator's discretion
* Part 2. Healthy subjects

  1. Clinically significant disorders or a medical history of active cardiovascular, respiratory , kidney, endocrine, hematological, digestive, central nervous system, psychiatric disease, or malignant tumor
  2. Clinically significant conditions that may affect the pharmacokinetics of amphotericin
  3. History of diseases that may affect the pharmacokinetics of amphotericin
  4. History of drug abuse
  5. History of hypersensitivity to ingredients of investigational products
  6. Unable to maintain proper contraception
  7. Pregnant or breast-feeding
  8. The following laboratory test results at screening

     * Hemoglobin \< 13.0 g/dL
     * Serum Creatinine \> 1.25 x UNL
     * eGFR \< 90 mL/min/1.73 m2
     * AST or ALT \> 1.25 x UNL
     * Total bilirubin \> 1.25 x UNL
     * CPK \> 1.5 x UNL
     * Systolic blood pressure ≥140 mmHg or ≤90 mmHg
     * Diastolic blood pressure ≥ 90 mmHg or ≤60 mmHg
     * Arrhythmia
  9. Before the first administration of investigational products

     * Participation to other clinical trials within 6 months
     * Whole blood donation within 60 days or component within 30 days
     * Drugs that induce or inhibit drug metabolism enzymes within 30 days
     * Vaccination within 7 days
     * Prescription drugs, herbal medicines, over-the-counters, or vitamins within 14 days
     * Grapefruit-containing foods within 7 days
     * Excessive exercise within 7 days
  10. Excessive caffeine and alcohol consumption, or a smoker
  11. Not eligible due to other reasons at the investigator's discretion

Primary outcomes:
measure: Cmax
timeFrame: 0 to 93 hr
measure: AUClast
timeFrame: 0 to 93 hr
Secondary outcomes:
measure: Cmax
timeFrame: 0 to 93 hr
measure: AUClast
timeFrame: 0 to 93 hr
measure: AUCinf
timeFrame: 0 to 93 hr
measure: tmax
timeFrame: 0 to 93 hr
measure: t1/2
timeFrame: 0 to 93 hr
measure: CL/F
timeFrame: 0 to 93 hr
measure: V/F
timeFrame: 0 to 93 hr
measure: Cmin,ss
timeFrame: 0 to 93 hr
measure: Cav,ss
timeFrame: 0 to 93 hr
measure: tmax,ss
timeFrame: 0 to 93 hr
measure: t1/2
timeFrame: 0 to 93 hr
measure: PTF (peak to trough fluctuation ratio)
timeFrame: 0 to 93 hr
measure: CLss/F
timeFrame: 0 to 93 hr
measure: Vd,ss/F
timeFrame: 0 to 93 hr
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea Seoul St. Mary's Hospital
state: Seocho-gu
Study officials:
References: