Pharmacokinetics and Safety of Oral Posaconazole (MK-5592)Tablets in Chinese Participants at High Risk for Invasive Fungal Infections (MK-5592-117)

NCT ID: NCT02387983

Last Updated: 2018-10-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-06
• Study Completion Date: 2016-05-02

Brief Summary

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.

Conditions

Fungal Infection

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Posaconazole

Intervention Type: DRUG

Posaconazole 300 mg solid oral tablet

Interventions

Posaconazole

Posaconazole 300 mg solid oral tablet

Intervention Type: DRUG

Other Intervention Names

MK-5592

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

Liu K, Wu D, Li J, Chen H, Ning H, Zhao T, Dai H, Chen L, Mangin E, Winchell GA, Waskin H, Jiang J, Qiu Y, Zhao XM. Pharmacokinetics and Safety of Posaconazole Tablet Formulation in Chinese Participants at High Risk for Invasive Fungal Infection. Adv Ther. 2020 May;37(5):2493-2506. doi: 10.1007/s12325-020-01341-x. Epub 2020 Apr 22.

Reference Type: DERIVED

PMID: 32319040 (View on PubMed)

Other Identifiers

5592-117

Identifier Type: -

Identifier Source: org_study_id