Pharmacokinetics and Safety of AmBisome and DKF-5122

Invasive Fungal Infections Clinical Trial

Official title:

Bioequivalence Study to Evaluate Pharmacokinetics and Safety of AmBisome and DKF-5122 in Indicated Patients and Healthy Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05749380
• Other study ID #: DKF-5122-BE
• Status: Completed
• Phase: Phase 1
• Start date: September 7, 2020
• Est. completion date: January 28, 2022

Study information

• Verified date: February 2023
• Source: Dongkook Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: January 28, 2022
• Est. primary completion date: January 28, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Febrile Neutropenia
• Invasive Fungal Infections
• Mycoses
• Neutropenic Fever

Intervention

Drug:
• AmBisome
Reference, dose of 3 mg/kg.
• DKF-5122
Test, dose of 3 mg/kg

Locations

Country	Name	City	State
Korea, Republic of	The Catholic University of Korea Seoul St. Mary's Hospital	Seoul	Seocho-gu

Sponsors (1)

Lead Sponsor	Collaborator
Dongkook Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax	Liposome encapsulated amphotericin B of healthy adult	0 to 93 hr
Primary	AUClast	Liposome encapsulated amphotericin B of healthy adult	0 to 93 hr
Secondary	Cmax	Unbound Amphotericin B of healthy adult	0 to 93 hr
Secondary	AUClast	Unbound Amphotericin B of healthy adult	0 to 93 hr
Secondary	AUCinf	Liposome encapsulated amphotericin B and Unbound Amphotericin B of healthy adult	0 to 93 hr
Secondary	tmax	Liposome encapsulated amphotericin B and Unbound Amphotericin B of healthy adult	0 to 93 hr
Secondary	t1/2	Liposome encapsulated amphotericin B and Unbound Amphotericin B of healthy adult	0 to 93 hr
Secondary	CL/F	Liposome encapsulated amphotericin B and Unbound Amphotericin B of healthy adult	0 to 93 hr
Secondary	V/F	Liposome encapsulated amphotericin B and Unbound Amphotericin B of healthy adult	0 to 93 hr
Secondary	Cmin,ss	Liposome encapsulated amphotericin B and Unbound Amphotericin B of indication patient	0 to 93 hr
Secondary	Cav,ss	Liposome encapsulated amphotericin B and Unbound Amphotericin B of indication patient	0 to 93 hr
Secondary	tmax,ss	Liposome encapsulated amphotericin B and Unbound Amphotericin B of indication patient	0 to 93 hr
Secondary	t1/2	Liposome encapsulated amphotericin B and Unbound Amphotericin B of indication patient	0 to 93 hr
Secondary	PTF (peak to trough fluctuation ratio)	Liposome encapsulated amphotericin B and Unbound Amphotericin B of indication patient	0 to 93 hr
Secondary	CLss/F	Liposome encapsulated amphotericin B and Unbound Amphotericin B of indication patient	0 to 93 hr
Secondary	Vd,ss/F	Liposome encapsulated amphotericin B and Unbound Amphotericin B of indication patient	0 to 93 hr