- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02387983
Pharmacokinetics and Safety of Oral Posaconazole (MK-5592)Tablets in Chinese Participants at High Risk for Invasive Fungal Infections (MK-5592-117)
September 10, 2018 updated by: Merck Sharp & Dohme LLC
Pharmacokinetics and Safety of Solid Oral Posaconazole (MK-5592, POS) in Chinese Subjects at High Risk for Invasive Fungal Infections
The purpose of this study is to evaluate the pharmacokinetics and safety of oral posaconazole tablets 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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
65
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Chinese participant
- Female of reproductive potential with a serum hCG level consistent with a nongravid state and agree to use 2 acceptable methods of birth control throughout the study
- Body Mass Index (BMI) >=15 and <=30 kg/m^2
- 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) or 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
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Posaconazole
Posaconazole 300 mg tablet (3 x 100 mg tablets) once every 12 hours on Day 1 and once-daily on Days 2 to 28
|
Posaconazole 300 mg solid oral tablet
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Steady-state Average Concentration (ssCavg) of Posaconazole on Day 8
Time Frame: Pre-dose and 2, 4, 6, 8, 12, and 24 hours post-dose on Day 8
|
The ssCavg was calculated in order to determine the percentage of participants achieving the pharmacokinetic (PK) target of ssCavg >500 ng/mL on Day 8 when plasma drug levels had reached steady state.
|
Pre-dose and 2, 4, 6, 8, 12, and 24 hours post-dose on Day 8
|
Steady-state Area Under the Concentration-time Curve (ssAUC0-24hr) of Posaconazole on Day 8
Time Frame: Pre-dose and 2, 4, 6, 8, 12, and 24 hours post-dose on Day 8
|
The ssAUC0-24hr was calculated to determine the mean plasma drug concentration in the Intensive and Sparse PK subgroup from immediately after dosing to 24 hours post-dose on Day 8. Results data are presented as the arithmetic mean (% arithmetic coefficient of variation [CV]), where CV is calculated as (100 x standard deviation/arithmetic mean).
|
Pre-dose and 2, 4, 6, 8, 12, and 24 hours post-dose on Day 8
|
Steady-state Maximum Concentration (ssCmax) of Posaconazole on Day 8
Time Frame: Pre-dose and 2, 4, 6, 8, 12, and 24 hours post-dose on Day 8
|
The ssCmax was calculated in order to determine the maximum post-dose plasma drug concentration in the Intensive and Sparse PK subgroup on Day 8. Results data are presented as the arithmetic mean (% arithmetic coefficient of variation [CV]), where CV is calculated as (100 x standard deviation/arithmetic mean).
|
Pre-dose and 2, 4, 6, 8, 12, and 24 hours post-dose on Day 8
|
Steady-state Minimum Concentration (ssCmin) of Posaconazole on Day 8
Time Frame: Pre-dose and 2, 4, 6, 8, 12, and 24 hours post-dose on Day 8
|
The ssCmin was calculated in order to determine the lowest measurable drug concentration in the Intensive and Sparse PK subgroup up to 24 hours post-dose on Day 8. Results data are presented as the arithmetic mean (% arithmetic coefficient of variation [CV]), where CV is calculated as (100 x standard deviation/arithmetic mean).
|
Pre-dose and 2, 4, 6, 8, 12, and 24 hours post-dose on Day 8
|
Time to Steady-state Maximum Concentration (ssTmax) of Posaconazole on Day 8
Time Frame: Pre-dose and 2, 4, 6, 8, 12, and 24 hours post-dose on Day 8
|
The ssTmax was calculated in order to determine the amount of time required to reach ssCmax in the Intensive and Sparse PK subgroup on Day 8.
|
Pre-dose and 2, 4, 6, 8, 12, and 24 hours post-dose on Day 8
|
AUC0-24hr of Posaconazole on Day 1
Time Frame: Pre-dose and 2, 4, 6, 8, 12, and 24 hours post-dose on Day 1
|
The AUC0-24hr was calculated to determine the mean plasma drug concentration from immediately after dosing to 24 hours post-dose in the Immediate and Sparse PK subgroup on Day 1. Results data are presented as the arithmetic mean (% arithmetic coefficient of variation [CV]), where CV is calculated as (100 x standard deviation/arithmetic mean).
|
Pre-dose and 2, 4, 6, 8, 12, and 24 hours post-dose on Day 1
|
Cmax of Posaconazole on Day 1
Time Frame: Pre-dose and 2, 4, 6, 8, 12, and 24 hours post-dose on Day 1
|
The Cmax was calculated to determine the maximum plasma drug concentration up to 24 hours post-dose in the Immediate and Sparse PK subgroup on Day 1. Results data are presented as the arithmetic mean (% arithmetic coefficient of variation [CV]), where CV is calculated as (100 x standard deviation/arithmetic mean).
|
Pre-dose and 2, 4, 6, 8, 12, and 24 hours post-dose on Day 1
|
Cmin of Posaconazole on Day 1
Time Frame: Pre-dose and 2, 4, 6, 8, 12, and 24 hours post-dose on Day 1
|
The Cmin was calculated in order to determine the lowest measurable drug concentration from immediately after dosing to 24 hours post-dose in the Immediate and Sparse PK subgroup on Day 1. Results data are presented as the arithmetic mean (% arithmetic coefficient of variation [CV]), where CV is calculated as (100 x standard deviation/arithmetic mean).
|
Pre-dose and 2, 4, 6, 8, 12, and 24 hours post-dose on Day 1
|
Tmax of Posaconazole on Day 1
Time Frame: Pre-dose and 2, 4, 6, 8, 12, and 24 hours post-dose on Day 1
|
The Tmax was calculated in order to determine the time required to reach Cmax in the Immediate and Sparse PK subgroup on Day 1.
|
Pre-dose and 2, 4, 6, 8, 12, and 24 hours post-dose on Day 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 6, 2015
Primary Completion (Actual)
May 2, 2016
Study Completion (Actual)
May 2, 2016
Study Registration Dates
First Submitted
March 9, 2015
First Submitted That Met QC Criteria
March 9, 2015
First Posted (Estimate)
March 13, 2015
Study Record Updates
Last Update Posted (Actual)
October 9, 2018
Last Update Submitted That Met QC Criteria
September 10, 2018
Last Verified
September 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Disease Attributes
- Bacterial Infections and Mycoses
- Infections
- Communicable Diseases
- Mycoses
- Invasive Fungal Infections
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Cytochrome P-450 Enzyme Inhibitors
- Hormone Antagonists
- Antifungal Agents
- Steroid Synthesis Inhibitors
- Antiprotozoal Agents
- Antiparasitic Agents
- 14-alpha Demethylase Inhibitors
- Trypanocidal Agents
- Posaconazole
Other Study ID Numbers
- 5592-117
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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