Pharmacokinetics and Safety of AmBisome and DKF-5122

Dongkook Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Invasive Fungal Infections; Neutropenic Fever

Treatments: Drug: DKF-5122; Drug: AmBisome

Study type: Interventional

Funder types: Industry

Identifiers

NCT05749380

DKF-5122-BE

Details and patient eligibility

About

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

Enrollment: 38 patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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38 participants in 4 patient groups

1A(RT)

Other group

Description:

Patients (AmBisome, DKF-5122)

Treatment:

Drug: AmBisome

Drug: DKF-5122

1B(TR)

Other group

Description:

Patients (DKF-5122, AmBisome)

Treatment:

Drug: AmBisome

Drug: DKF-5122

2A(RT)

Other group

Description:

Healthy subjects (AmBisome, DKF-5122)

Treatment:

Drug: AmBisome

Drug: DKF-5122

2B(TR)

Other group

Description:

Healthy subjects (DKF-5122, AmBisome)

Treatment:

Drug: AmBisome

Drug: DKF-5122