Pharmacokinetics and Safety of Posaconazole Tablet in Participants at High Risk for Invasive Fungal Infections (MK-5592-065/P05615)
Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Fungal Infections
Intervention: Posaconazole 200 mg (Drug); Posaconazole 300 mg (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Merck Sharp & Dohme Corp.
Summary
The purpose of this study is to collect pharmacokinetic (PK) information related to how well
posaconazole tablet is distributed in the body and to determine the safety of this new
formulation. The study consists of a Phase 1B study that includes participants with
neutropenia undergoing chemotherapy for acute myelogenous leukemia (AML) or myelodysplasia
(MDS) and a Phase 3 study that includes participants who are undergoing chemotherapy for AML
or MDS and participants who are recipients of allogeneic hematopoietic stem cell transplant
(HSCT).
Clinical Details
Official title: Pharmacokinetics and Safety of Solid Oral Posaconazole (SCH 56592) in Subjects at High Risk for Invasive Fungal Infections (Phase 1b; Protocol No. P05615)
Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: Average Concentration (Cavg) of Posaconazole TabletMinimum Concentration (Cmin) of Posaconazole Tablet Maximum Concentration (Cmax) of Posaconazole Tablet Time to Maximum Concentration (Tmax) of Posaconazole Tablet Apparent Total Body Clearance (CL/F) for Posaconazole Tablet
Detailed description:
Participants with a blood disease or cancer that can affect their infection-fighting white
blood cells and those who have undergone a hematopoietic stem cell transplant (HSCT) and are
receiving immunosuppressive therapy and have or are at risk of graft-vs-host disease (GVHD)
are eligible for the study. These blood diseases and their treatments can weaken the immune
system and may put individuals at high risk for a serious fungal infection of their internal
organs or blood (invasive fungal infection). As these infections can be hard to detect early
and can be life-threatening, many physicians believe that individuals diagnosed with these
diseases should receive antifungal therapy to try to lower their risk of getting this type
of infection.
Enrollment into this study will take place in several stages (parts). The determination of
which part a participant will be in is based on which part is open at the site at the time
of enrollment.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Body weight >34 kg (75 lb) and of any race/ethnicity
- Able to swallow oral tablets whole
- Anticipated (likely to develop within 3-5 days) or documented neutropenia due to
chemotherapy, chemotherapy for a new diagnosis of acute myelogenous leukemia (AML),
or AML in first relapse; myelodysplastic syndromes (MDS) in transformation to AML;
allogeneic hematopoietic stem cell transplant (HSCT) participants in the
pre-engraftment period or in the post-engraftment period if they are receiving
immunosuppressive therapy for graft versus host disease
Exclusion Criteria:
- Female must not be pregnant, must not intend to become pregnant
during the study, and must not be nursing
- History of hypersensitivity to azoles
- Moderate or severe liver dysfunction defined as aspartate aminotransferase (AST) or
alanine aminotransferase (ALT) levels greater than three times the upper limit of
normal (ULN), AND a total bilirubin level greater than two times the ULN
- Electrocardiogram (ECG) with corrected QTc interval greater than 500 msec
- Posaconazole within 10 days before study enrollment
- Receipt of systemic antifungal therapy within 30 days of study enrollment for reasons
other than antifungal prophylaxis
- Evidence of known or suspected invasive or systemic fungal infection at baseline
- Known or suspected history of Gilbert's disease
- Creatinine clearance levels below 30 mL/min
Locations and Contacts
Additional Information
Starting date: June 2009
Last updated: November 14, 2014
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