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Pharmacokinetics and Safety of AmBisome and DKF-5122

Primary Purpose

Invasive Fungal Infections, Neutropenic Fever

Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
AmBisome
DKF-5122
Sponsored by
Dongkook Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Invasive Fungal Infections

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Part 1. Patients Age 19 years and older Empirical therapy for presumed fungal infection in febrile, neutropenic patients Voluntarily decided to participate in the study and signed the informed consent form Having contraception during the study Part 2. Healthy subjects Age 19 to 45 years Body weight 55 kg or more, within ±20% of the ideal body weight Having no congenital or chronic disease within the last 5 years. Voluntarily decided to participate in the study and signed the informed consent form Having contraception during the study Exclusion Criteria: Part 1. Patients Clinically significant conditions that may affect the pharmacokinetics of amphotericin History of diseases that may affect the pharmacokinetics of amphotericin History of drug abuse History of hypersensitivity to ingredients of investigational products Unable to maintain proper contraception Pregnant or breast-feeding 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 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 Excessive caffeine and alcohol consumption, or a smoker Not eligible due to other reasons at the investigator's discretion Part 2. Healthy subjects Clinically significant disorders or a medical history of active cardiovascular, respiratory , kidney, endocrine, hematological, digestive, central nervous system, psychiatric disease, or malignant tumor Clinically significant conditions that may affect the pharmacokinetics of amphotericin History of diseases that may affect the pharmacokinetics of amphotericin History of drug abuse History of hypersensitivity to ingredients of investigational products Unable to maintain proper contraception Pregnant or breast-feeding 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 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 Excessive caffeine and alcohol consumption, or a smoker Not eligible due to other reasons at the investigator's discretion

Sites / Locations

  • The Catholic University of Korea Seoul St. Mary's Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Other

Other

Other

Arm Label

1A(RT)

1B(TR)

2A(RT)

2B(TR)

Arm Description

Patients (AmBisome, DKF-5122)

Patients (DKF-5122, AmBisome)

Healthy subjects (AmBisome, DKF-5122)

Healthy subjects (DKF-5122, AmBisome)

Outcomes

Primary Outcome Measures

Cmax
Liposome encapsulated amphotericin B of healthy adult
AUClast
Liposome encapsulated amphotericin B of healthy adult

Secondary Outcome Measures

Cmax
Unbound Amphotericin B of healthy adult
AUClast
Unbound Amphotericin B of healthy adult
AUCinf
Liposome encapsulated amphotericin B and Unbound Amphotericin B of healthy adult
tmax
Liposome encapsulated amphotericin B and Unbound Amphotericin B of healthy adult
t1/2
Liposome encapsulated amphotericin B and Unbound Amphotericin B of healthy adult
CL/F
Liposome encapsulated amphotericin B and Unbound Amphotericin B of healthy adult
V/F
Liposome encapsulated amphotericin B and Unbound Amphotericin B of healthy adult
Cmin,ss
Liposome encapsulated amphotericin B and Unbound Amphotericin B of indication patient
Cav,ss
Liposome encapsulated amphotericin B and Unbound Amphotericin B of indication patient
tmax,ss
Liposome encapsulated amphotericin B and Unbound Amphotericin B of indication patient
t1/2
Liposome encapsulated amphotericin B and Unbound Amphotericin B of indication patient
PTF (peak to trough fluctuation ratio)
Liposome encapsulated amphotericin B and Unbound Amphotericin B of indication patient
CLss/F
Liposome encapsulated amphotericin B and Unbound Amphotericin B of indication patient
Vd,ss/F
Liposome encapsulated amphotericin B and Unbound Amphotericin B of indication patient

Full Information

First Posted
February 16, 2023
Last Updated
February 26, 2023
Sponsor
Dongkook Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05749380
Brief Title
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

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
September 7, 2020 (Actual)
Primary Completion Date
January 28, 2022 (Actual)
Study Completion Date
January 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dongkook Pharmaceutical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Invasive Fungal Infections, Neutropenic Fever

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1A(RT)
Arm Type
Other
Arm Description
Patients (AmBisome, DKF-5122)
Arm Title
1B(TR)
Arm Type
Other
Arm Description
Patients (DKF-5122, AmBisome)
Arm Title
2A(RT)
Arm Type
Other
Arm Description
Healthy subjects (AmBisome, DKF-5122)
Arm Title
2B(TR)
Arm Type
Other
Arm Description
Healthy subjects (DKF-5122, AmBisome)
Intervention Type
Drug
Intervention Name(s)
AmBisome
Intervention Description
Reference, dose of 3 mg/kg.
Intervention Type
Drug
Intervention Name(s)
DKF-5122
Intervention Description
Test, dose of 3 mg/kg
Primary Outcome Measure Information:
Title
Cmax
Description
Liposome encapsulated amphotericin B of healthy adult
Time Frame
0 to 93 hr
Title
AUClast
Description
Liposome encapsulated amphotericin B of healthy adult
Time Frame
0 to 93 hr
Secondary Outcome Measure Information:
Title
Cmax
Description
Unbound Amphotericin B of healthy adult
Time Frame
0 to 93 hr
Title
AUClast
Description
Unbound Amphotericin B of healthy adult
Time Frame
0 to 93 hr
Title
AUCinf
Description
Liposome encapsulated amphotericin B and Unbound Amphotericin B of healthy adult
Time Frame
0 to 93 hr
Title
tmax
Description
Liposome encapsulated amphotericin B and Unbound Amphotericin B of healthy adult
Time Frame
0 to 93 hr
Title
t1/2
Description
Liposome encapsulated amphotericin B and Unbound Amphotericin B of healthy adult
Time Frame
0 to 93 hr
Title
CL/F
Description
Liposome encapsulated amphotericin B and Unbound Amphotericin B of healthy adult
Time Frame
0 to 93 hr
Title
V/F
Description
Liposome encapsulated amphotericin B and Unbound Amphotericin B of healthy adult
Time Frame
0 to 93 hr
Title
Cmin,ss
Description
Liposome encapsulated amphotericin B and Unbound Amphotericin B of indication patient
Time Frame
0 to 93 hr
Title
Cav,ss
Description
Liposome encapsulated amphotericin B and Unbound Amphotericin B of indication patient
Time Frame
0 to 93 hr
Title
tmax,ss
Description
Liposome encapsulated amphotericin B and Unbound Amphotericin B of indication patient
Time Frame
0 to 93 hr
Title
t1/2
Description
Liposome encapsulated amphotericin B and Unbound Amphotericin B of indication patient
Time Frame
0 to 93 hr
Title
PTF (peak to trough fluctuation ratio)
Description
Liposome encapsulated amphotericin B and Unbound Amphotericin B of indication patient
Time Frame
0 to 93 hr
Title
CLss/F
Description
Liposome encapsulated amphotericin B and Unbound Amphotericin B of indication patient
Time Frame
0 to 93 hr
Title
Vd,ss/F
Description
Liposome encapsulated amphotericin B and Unbound Amphotericin B of indication patient
Time Frame
0 to 93 hr

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Part 1. Patients Age 19 years and older Empirical therapy for presumed fungal infection in febrile, neutropenic patients Voluntarily decided to participate in the study and signed the informed consent form Having contraception during the study Part 2. Healthy subjects Age 19 to 45 years Body weight 55 kg or more, within ±20% of the ideal body weight Having no congenital or chronic disease within the last 5 years. Voluntarily decided to participate in the study and signed the informed consent form Having contraception during the study Exclusion Criteria: Part 1. Patients Clinically significant conditions that may affect the pharmacokinetics of amphotericin History of diseases that may affect the pharmacokinetics of amphotericin History of drug abuse History of hypersensitivity to ingredients of investigational products Unable to maintain proper contraception Pregnant or breast-feeding 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 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 Excessive caffeine and alcohol consumption, or a smoker Not eligible due to other reasons at the investigator's discretion Part 2. Healthy subjects Clinically significant disorders or a medical history of active cardiovascular, respiratory , kidney, endocrine, hematological, digestive, central nervous system, psychiatric disease, or malignant tumor Clinically significant conditions that may affect the pharmacokinetics of amphotericin History of diseases that may affect the pharmacokinetics of amphotericin History of drug abuse History of hypersensitivity to ingredients of investigational products Unable to maintain proper contraception Pregnant or breast-feeding 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 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 Excessive caffeine and alcohol consumption, or a smoker Not eligible due to other reasons at the investigator's discretion
Facility Information:
Facility Name
The Catholic University of Korea Seoul St. Mary's Hospital
City
Seoul
State/Province
Seocho-gu
ZIP/Postal Code
06591
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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Pharmacokinetics and Safety of AmBisome and DKF-5122

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