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

Merck Sharp & Dohme (MSD)

Status and phase

Completed

Phase 1

Conditions

Fungal Infection

Treatments

Drug: Posaconazole

Study type

Interventional

Funder types

Industry

Identifiers

NCT02387983

5592-117

Details and patient eligibility

About

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.

Enrollment

65 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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