Back to resultsPharmacokinetics and Safety of Intravenous Posaconazole (MK-5592) in Chinese Participants at High Risk for Invasive Fungal Infections (MK-5592-120)
Primary Purpose
Fungal Infection
Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Posaconazole
Sponsored by
About this trial
This is an interventional prevention trial for Fungal Infection
Eligibility Criteria
Inclusion Criteria:
- Chinese participant
- Female of reproductive potential with a serum of beta human chorionic gonadotropin (β-hCG) level consistent with a nongravid state and agree and/or have their partner use 2 acceptable methods of birth control throughout the study
- Body Mass Index (BMI) >=15 and <=30 kg/m^2
- Have a central line catheter or peripherally central venous catheter in place
- Anticipated or documented prolonged neutropenia and likely to last for at least 7 days due to: a) standard intensive chemotherapy, anthracycline-based or other accepted regimen (excluding any investigational agent) for a new diagnosis of acute myelogenous leukemia (AML); b)chemotherapy for AML in first relapse; or c) therapy for myelodysplastic syndromes in transformation to AML or other diagnoses of secondary AML (therapy related, antecedent hematological disorders) other than chronic myelogenous leukemia in blast crisis
- Free from any clinically significant disease other than the primary hematologic disease that would interfere with administration of study medication or study evaluations
- Able to tolerate central IV solution
Exclusion Criteria:
- Pregnant, intends to become pregnant during the study, or has been nursing
- Mentally or legally incapacitated, has significant emotional problems, or has clinically significant psychiatric disorder over the last 5 years
- Received systemic antifungal therapy (oral, intravenous, or inhaled) within 30 days of study enrollment for reasons other than antifungal prophylaxis
- Known or suspected invasive or systemic fungal infection
- Taken posaconazole within 10 days prior to study enrollment
- Major surgery, donated or lost 1 unit of blood, or participated in another investigational study within 4 weeks prior to the study
- Type 1 hypersensitivity or idiosyncratic reactions to azole agents
- Significant multiple or severe allergies, or has had an anaphylactic reaction or significant intolerability to drugs or food
- Moderate or severe liver dysfunction
- Chronic active hepatitis, cirrhosis, Hepatocellular Carcinoma (HCC), or other hepatic disease caused by a virus
- Previous electrocardiogram with a prolonged QTc interval
- Prior enrollment in this study or other posaconazole studies within 90 days of study entry
- Eastern Cooperative Oncology Group (ECOG) performance status was >2 prior to induction chemotherapy for the underlying disease
- Known or suspected Gilbert's disease.
Sites / Locations
- Guangdong General Hospital, Guangdong Academy of Medical Science ( Site 0002)
- The First Affiliated Hospital of Soochow University ( Site 0004)
- Peking University People's Hospital ( Site 0008)
- Peking University Third Hospital ( Site 0009)
- Peking Union Medical College Hospital ( Site 0006)
- Shanghai General Hospital ( Site 0007)
- Institute of Hematology and Blood Diseases Hosp CAMS&PUMC ( Site 0001)
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Posaconazole
Arm Description
All participants will receive posaconazole 300 mg intravenous (IV) infusion twice on Day 1 followed by 300 mg IV infusion once daily on Days 2 to 10 (±1). At the discretion of the investigator, participants will received posaconazole 300 mg IV infusion once daily or 200 mg oral suspension three times daily for up to 18 additional days.
Outcomes
Primary Outcome Measures
Steady State (ss) Average Concentration (Cavg) of Posaconazole of Serial PK (Subgroup 1) on Day 10
Characterization of the pharmacokinetics (PK) parameters of POS determined from plasma samples taken at steady-state after receiving IV administration of 300 mg POS twice a day (BID) on Day 1 and then 300 mg POS QD until at least Day 10. Steady-state Cavg, where Cavg is defined as AUC0-24hr divided by the dosing interval.
Subgroup 1 - Serial PK, multiple same-day blood draw, performed specifically for determination of PK parameters of Cavg, AUC, Cmin, Cmax, Tmax and Total Body Clearance in addition to plasma trough determination.
Subgroup 2 - Sparse PK, once a day blood draw, performed for plasma trough determination only.
Percentage of Participants With ssCavg ≥500 ng/mL of Serial PK (Subgroup 1) on Day 10
Characterization of the PK parameters of POS determined from plasma samples taken at steady-state after receiving IV administration of 300 mg POS twice a day (BID) on Day 1 and then 300 mg POS QD until at least Day 10. Steady-state Cavg, where Cavg is defined as AUC0-24hr divided by the dosing interval. The percentage of participants with ssCavg ≥500 ng/mL are presented.
Subgroup 1 - Serial PK, multiple same-day blood draw, performed specifically for determination of PK parameters of Cavg, AUC, Cmin, Cmax, Tmax and Total Body Clearance in addition to plasma trough determination.
Subgroup 2 - Sparse PK, once a day blood draw, performed for plasma trough determination only.
Steady-state Area Under the Concentration-time Curve (ssAUC0-24hr) of POS of Serial PK (Subgroup 1) on Day 10
Characterization of the PK parameters of POS determined from plasma samples taken at steady-state after receiving IV administration of 300 mg POS twice a day (BID) on Day 1 and then 300 mg POS QD until at least Day 10. AUC0-24 is defined as area under the plasma concentration-time curve from time 0 extrapolated to 24 hours.
Subgroup 1 - Serial PK, multiple same-day blood draw, performed specifically for determination of PK parameters of Cavg, AUC, Cmin, Cmax, Tmax and Total Body Clearance in addition to plasma trough determination.
Subgroup 2 - Sparse PK, once a day blood draw, performed for plasma trough determination only.
Steady State Maximum Concentration (ssCmax) of POS of Serial PK (Subgroup 1) on Day 10
Characterization of the PK parameters of POS determined from plasma samples taken at steady-state after receiving IV administration of 300 mg POS twice a day (BID) on Day 1 and then 300 mg POS QD until at least Day 10. Cmax is defined as the maximum concentration of POS in plasma.
Subgroup 1 - Serial PK, multiple same-day blood draw, performed specifically for determination of PK parameters of Cavg, AUC, Cmin, Cmax, Tmax and Total Body Clearance in addition to plasma trough determination.
Subgroup 2 - Sparse PK, once a day blood draw, performed for plasma trough determination only.
Steady State Minimum Concentration (ssCmin) of POS of Serial PK (Subgroup 1) on Day 10
Characterization of the PK parameters of POS determined from plasma samples taken at steady-state after receiving IV administration of 300 mg POS twice a day (BID) on Day 1 and then 300 mg POS QD until at least Day 10. Cmin is defined as the minimum concentration of POS in plasma.
Subgroup 1 - Serial PK, multiple same-day blood draw, performed specifically for determination of PK parameters of Cavg, AUC, Cmin, Cmax, Tmax and Total Body Clearance in addition to plasma trough determination.
Subgroup 2 - Sparse PK, once a day blood draw, performed for plasma trough determination only.
Time to Steady-state Maximum Concentration (ssTmax) of POS of Serial PK (Subgroup 1) on Day 10
Characterization of the PK parameters of POS determined from plasma samples taken at steady-state after receiving IV administration of 300 mg POS twice a day (BID) on Day 1 and then 300 mg POS QD until at least Day 10. Tmax is defined as the time it takes to achieve maximum concentration of POS in plasma.
Subgroup 1 - Serial PK, multiple same-day blood draw, performed specifically for determination of PK parameters of Cavg, AUC, Cmin, Cmax, Tmax and Total Body Clearance in addition to plasma trough determination.
Subgroup 2 - Sparse PK, once a day blood draw, performed for plasma trough determination only.
Total Body Clearance (CL) of POS of Serial PK (Subgroup 1) on Day 10
Characterization of the PK parameters of POS determined from plasma samples taken at steady-state after receiving IV administration of 300 mg POS twice a day (BID) on Day 1 and then 300 mg POS QD until at least Day 10. CL is defined as the time it takes for POS to be completely removed from the body's blood stream.
Subgroup 1 - Serial PK, multiple same-day blood draw, performed specifically for determination of PK parameters of Cavg, AUC, Cmin, Cmax, Tmax and Total Body Clearance in addition to plasma trough determination.
Subgroup 2 - Sparse PK, once a day blood draw, performed for plasma trough determination only.
POS Plasma Trough Concentrations in the Serial PK and Sparse PK Subgroups
Pre-dose plasma trough concentrations by study day between serial PK and Sparse PK - where serial PK is defined as multiple serial blood sampling of more than 6 timepoints; and sparse PK is defined as few blood samples taken and single or limited timepoints
Secondary Outcome Measures
Adverse Events (AEs)
Number of participants with one or more AEs where AEs are defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Discontinuations Due to an AE
Number of participants discontinued from study medication due to an AE where AEs are defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Medically Significant Changes in Clinical Laboratory Results - Lab Values
The number of participants with clinical laboratory values outside of normal range
Medically Significant Changes in Clinical Laboratory Results - Vital Signs
The number of participants with values of vital signs outside of normal range
Survival Status
Survival assessment as to whether a participant is alive or dead, included all participants who died - 2 during study treatment, 1 during safety follow-up, 2 during survival follow-up (Day 60 to 70 post dose), and 1 participant who died during serious AE (SAE) follow-up at 97 days after first dose but was beyond the safety and the survival follow-up period
Participants With Invasive Fungal Infection (IFI)
Number of participants with possible, probable, or proven IFI observed during the whole study period
Full Information
NCT ID
NCT03336502
First Posted
November 6, 2017
Last Updated
December 2, 2019
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT03336502
Brief Title
Pharmacokinetics and Safety of Intravenous Posaconazole (MK-5592) in Chinese Participants at High Risk for Invasive Fungal Infections (MK-5592-120)
Official Title
Pharmacokinetics and Safety of Intravenous Posaconazole (MK-5592, POS) in Chinese Subjects at High Risk for Invasive Fungal Infections
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
December 20, 2017 (Actual)
Primary Completion Date
November 26, 2018 (Actual)
Study Completion Date
November 26, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the pharmacokinetics and safety of posaconazole intravenous solution in Chinese participants at high risk for invasive fungal infections. Neutropenic participants undergoing chemotherapy for acute myelogenous leukemia or myelodysplastic syndromes will be enrolled in the study. The primary hypothesis is to evaluate the pharmacokinetic parameters of intravenous (IV) posaconazole (POS) solution in Chinese participants at high risk of invasive fungal infections and determine the percentage of Chinese participants who reach steady-state concentration averages of POS in blood plasma of 500 ng/ml and higher. Two subgroups were evaluated: Subgroup 1 from serial PK blood draw sampling and Subgroup 2 from sparse limited PK blood draw sampling.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fungal Infection
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Posaconazole
Arm Type
Experimental
Arm Description
All participants will receive posaconazole 300 mg intravenous (IV) infusion twice on Day 1 followed by 300 mg IV infusion once daily on Days 2 to 10 (±1). At the discretion of the investigator, participants will received posaconazole 300 mg IV infusion once daily or 200 mg oral suspension three times daily for up to 18 additional days.
Intervention Type
Drug
Intervention Name(s)
Posaconazole
Other Intervention Name(s)
MK-5592, Noxafil
Intervention Description
Posaconazole 18 mg/mL IV solution; posaconazole 40 mg/mL oral suspension
Primary Outcome Measure Information:
Title
Steady State (ss) Average Concentration (Cavg) of Posaconazole of Serial PK (Subgroup 1) on Day 10
Description
Characterization of the pharmacokinetics (PK) parameters of POS determined from plasma samples taken at steady-state after receiving IV administration of 300 mg POS twice a day (BID) on Day 1 and then 300 mg POS QD until at least Day 10. Steady-state Cavg, where Cavg is defined as AUC0-24hr divided by the dosing interval.
Subgroup 1 - Serial PK, multiple same-day blood draw, performed specifically for determination of PK parameters of Cavg, AUC, Cmin, Cmax, Tmax and Total Body Clearance in addition to plasma trough determination.
Subgroup 2 - Sparse PK, once a day blood draw, performed for plasma trough determination only.
Time Frame
Serial PK (Subgroup 1) on Day 10 at pre-dose, 1 hr. post start of infusion (SOI), end of infusion (EOI), 15 min. after EOI and 4, 8, 12, 24 hours post SOI
Title
Percentage of Participants With ssCavg ≥500 ng/mL of Serial PK (Subgroup 1) on Day 10
Description
Characterization of the PK parameters of POS determined from plasma samples taken at steady-state after receiving IV administration of 300 mg POS twice a day (BID) on Day 1 and then 300 mg POS QD until at least Day 10. Steady-state Cavg, where Cavg is defined as AUC0-24hr divided by the dosing interval. The percentage of participants with ssCavg ≥500 ng/mL are presented.
Subgroup 1 - Serial PK, multiple same-day blood draw, performed specifically for determination of PK parameters of Cavg, AUC, Cmin, Cmax, Tmax and Total Body Clearance in addition to plasma trough determination.
Subgroup 2 - Sparse PK, once a day blood draw, performed for plasma trough determination only.
Time Frame
Serial PK (Subgroup 1) on Day 10 at pre-dose, 1 hr. post start of infusion (SOI), end of infusion (EOI), 15 min. after EOI and 4, 8, 12, 24 hours post SOI
Title
Steady-state Area Under the Concentration-time Curve (ssAUC0-24hr) of POS of Serial PK (Subgroup 1) on Day 10
Description
Characterization of the PK parameters of POS determined from plasma samples taken at steady-state after receiving IV administration of 300 mg POS twice a day (BID) on Day 1 and then 300 mg POS QD until at least Day 10. AUC0-24 is defined as area under the plasma concentration-time curve from time 0 extrapolated to 24 hours.
Subgroup 1 - Serial PK, multiple same-day blood draw, performed specifically for determination of PK parameters of Cavg, AUC, Cmin, Cmax, Tmax and Total Body Clearance in addition to plasma trough determination.
Subgroup 2 - Sparse PK, once a day blood draw, performed for plasma trough determination only.
Time Frame
Serial PK (Subgroup 1) on Day 10 at pre-dose, 1 hr. post start of infusion (SOI), end of infusion (EOI), 15 min. after EOI and 4, 8, 12, 24 hours post SOI
Title
Steady State Maximum Concentration (ssCmax) of POS of Serial PK (Subgroup 1) on Day 10
Description
Characterization of the PK parameters of POS determined from plasma samples taken at steady-state after receiving IV administration of 300 mg POS twice a day (BID) on Day 1 and then 300 mg POS QD until at least Day 10. Cmax is defined as the maximum concentration of POS in plasma.
Subgroup 1 - Serial PK, multiple same-day blood draw, performed specifically for determination of PK parameters of Cavg, AUC, Cmin, Cmax, Tmax and Total Body Clearance in addition to plasma trough determination.
Subgroup 2 - Sparse PK, once a day blood draw, performed for plasma trough determination only.
Time Frame
Serial PK (Subgroup 1) on Day 10 at pre-dose, 1 hr. post start of infusion (SOI), end of infusion (EOI), 15 min. after EOI and 4, 8, 12, 24 hours post SOI
Title
Steady State Minimum Concentration (ssCmin) of POS of Serial PK (Subgroup 1) on Day 10
Description
Characterization of the PK parameters of POS determined from plasma samples taken at steady-state after receiving IV administration of 300 mg POS twice a day (BID) on Day 1 and then 300 mg POS QD until at least Day 10. Cmin is defined as the minimum concentration of POS in plasma.
Subgroup 1 - Serial PK, multiple same-day blood draw, performed specifically for determination of PK parameters of Cavg, AUC, Cmin, Cmax, Tmax and Total Body Clearance in addition to plasma trough determination.
Subgroup 2 - Sparse PK, once a day blood draw, performed for plasma trough determination only.
Time Frame
Serial PK (Subgroup 1) on Day 10 at pre-dose, 1 hr. post start of infusion (SOI), end of infusion (EOI), 15 min. after EOI and 4, 8, 12, 24 hours post SOI
Title
Time to Steady-state Maximum Concentration (ssTmax) of POS of Serial PK (Subgroup 1) on Day 10
Description
Characterization of the PK parameters of POS determined from plasma samples taken at steady-state after receiving IV administration of 300 mg POS twice a day (BID) on Day 1 and then 300 mg POS QD until at least Day 10. Tmax is defined as the time it takes to achieve maximum concentration of POS in plasma.
Subgroup 1 - Serial PK, multiple same-day blood draw, performed specifically for determination of PK parameters of Cavg, AUC, Cmin, Cmax, Tmax and Total Body Clearance in addition to plasma trough determination.
Subgroup 2 - Sparse PK, once a day blood draw, performed for plasma trough determination only.
Time Frame
Serial PK (Subgroup 1) on Day 10 at pre-dose, 1 hr. post start of infusion (SOI), end of infusion (EOI), 15 min. after EOI and 4, 8, 12, 24 hours post SOI
Title
Total Body Clearance (CL) of POS of Serial PK (Subgroup 1) on Day 10
Description
Characterization of the PK parameters of POS determined from plasma samples taken at steady-state after receiving IV administration of 300 mg POS twice a day (BID) on Day 1 and then 300 mg POS QD until at least Day 10. CL is defined as the time it takes for POS to be completely removed from the body's blood stream.
Subgroup 1 - Serial PK, multiple same-day blood draw, performed specifically for determination of PK parameters of Cavg, AUC, Cmin, Cmax, Tmax and Total Body Clearance in addition to plasma trough determination.
Subgroup 2 - Sparse PK, once a day blood draw, performed for plasma trough determination only.
Time Frame
Serial PK (Subgroup 1) on Day 10 at pre-dose, 1 hr. post start of infusion (SOI), end of infusion (EOI), 15 min. after EOI and 4, 8, 12, 24 hours post SOI
Title
POS Plasma Trough Concentrations in the Serial PK and Sparse PK Subgroups
Description
Pre-dose plasma trough concentrations by study day between serial PK and Sparse PK - where serial PK is defined as multiple serial blood sampling of more than 6 timepoints; and sparse PK is defined as few blood samples taken and single or limited timepoints
Time Frame
Day 3, Day 6, Day 10, Day 15, Day 22, Day 28
Secondary Outcome Measure Information:
Title
Adverse Events (AEs)
Description
Number of participants with one or more AEs where AEs are defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Time Frame
Up to 58 days
Title
Discontinuations Due to an AE
Description
Number of participants discontinued from study medication due to an AE where AEs are defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Time Frame
Up to 28 days
Title
Medically Significant Changes in Clinical Laboratory Results - Lab Values
Description
The number of participants with clinical laboratory values outside of normal range
Time Frame
Up to 28 days
Title
Medically Significant Changes in Clinical Laboratory Results - Vital Signs
Description
The number of participants with values of vital signs outside of normal range
Time Frame
Up to 28 days
Title
Survival Status
Description
Survival assessment as to whether a participant is alive or dead, included all participants who died - 2 during study treatment, 1 during safety follow-up, 2 during survival follow-up (Day 60 to 70 post dose), and 1 participant who died during serious AE (SAE) follow-up at 97 days after first dose but was beyond the safety and the survival follow-up period
Time Frame
Up to 98 days
Title
Participants With Invasive Fungal Infection (IFI)
Description
Number of participants with possible, probable, or proven IFI observed during the whole study period
Time Frame
Up to 28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Chinese participant
Female of reproductive potential with a serum of beta human chorionic gonadotropin (β-hCG) level consistent with a nongravid state and agree and/or have their partner use 2 acceptable methods of birth control throughout the study
Body Mass Index (BMI) >=15 and <=30 kg/m^2
Have a central line catheter or peripherally central venous catheter in place
Anticipated or documented prolonged neutropenia and likely to last for at least 7 days due to: a) standard intensive chemotherapy, anthracycline-based or other accepted regimen (excluding any investigational agent) for a new diagnosis of acute myelogenous leukemia (AML); b)chemotherapy for AML in first relapse; or c) therapy for myelodysplastic syndromes in transformation to AML or other diagnoses of secondary AML (therapy related, antecedent hematological disorders) other than chronic myelogenous leukemia in blast crisis
Free from any clinically significant disease other than the primary hematologic disease that would interfere with administration of study medication or study evaluations
Able to tolerate central IV solution
Exclusion Criteria:
Pregnant, intends to become pregnant during the study, or has been nursing
Mentally or legally incapacitated, has significant emotional problems, or has clinically significant psychiatric disorder over the last 5 years
Received systemic antifungal therapy (oral, intravenous, or inhaled) within 30 days of study enrollment for reasons other than antifungal prophylaxis
Known or suspected invasive or systemic fungal infection
Taken posaconazole within 10 days prior to study enrollment
Major surgery, donated or lost 1 unit of blood, or participated in another investigational study within 4 weeks prior to the study
Type 1 hypersensitivity or idiosyncratic reactions to azole agents
Significant multiple or severe allergies, or has had an anaphylactic reaction or significant intolerability to drugs or food
Moderate or severe liver dysfunction
Chronic active hepatitis, cirrhosis, Hepatocellular Carcinoma (HCC), or other hepatic disease caused by a virus
Previous electrocardiogram with a prolonged QTc interval
Prior enrollment in this study or other posaconazole studies within 90 days of study entry
Eastern Cooperative Oncology Group (ECOG) performance status was >2 prior to induction chemotherapy for the underlying disease
Known or suspected Gilbert's disease.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
Facility Information:
Facility Name
Guangdong General Hospital, Guangdong Academy of Medical Science ( Site 0002)
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Facility Name
The First Affiliated Hospital of Soochow University ( Site 0004)
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215006
Country
China
Facility Name
Peking University People's Hospital ( Site 0008)
City
Beijing
ZIP/Postal Code
100044
Country
China
Facility Name
Peking University Third Hospital ( Site 0009)
City
Beijing
ZIP/Postal Code
100191
Country
China
Facility Name
Peking Union Medical College Hospital ( Site 0006)
City
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
Shanghai General Hospital ( Site 0007)
City
Shanghai
ZIP/Postal Code
200080
Country
China
Facility Name
Institute of Hematology and Blood Diseases Hosp CAMS&PUMC ( Site 0001)
City
Tianjin
ZIP/Postal Code
300020
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php
Citations:
PubMed Identifier
35167031
Citation
Wu D, Mi Y, Weng J, Zhuang J, Ke X, Wang C, Liu K, Martinho M, Winchell GA, Zang Y, Xu L. Phase 1b/3 Pharmacokinetics and Safety Study of Intravenous Posaconazole in Adult Asian Participants at High Risk for Invasive Fungal Infections. Adv Ther. 2022 Apr;39(4):1697-1710. doi: 10.1007/s12325-021-02012-1. Epub 2022 Feb 15.
Results Reference
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Pharmacokinetics and Safety of Intravenous Posaconazole (MK-5592) in Chinese Participants at High Risk for Invasive Fungal Infections (MK-5592-120)
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