NEWS HIGHLIGHTS
Published Studies Related to Noxafil (Posaconazole)
Effects of oral posaconazole on the pharmacokinetics of atazanavir alone and with ritonavir or with efavirenz in healthy adult volunteers. [2009.08.01]
BACKGROUND: Patients with HIV/AIDS are at increased risk for opportunistic fungal infections. These patients may require concomitant treatment with antiretrovirals and azole antifungals, and interactions between these classes of drugs should be anticipated... CONCLUSIONS: Frequent monitoring of adverse events and toxicity related to antiviral exposure is recommended in the event of coadministration of posaconazole and ATV with or without ritonavir. In addition, because of decreased posaconazole exposure, coadministration with efavirenz should be avoided unless the benefit to patients outweighs the risk.
Pharmacokinetics of posaconazole administered orally or by nasogastric tube in healthy volunteers. [2009.07]
The use of a nasogastric tube is one means of administering antifungal therapy to critically ill patients unable to receive medication via the oral route. This was a phase 1, open-label, single-center, randomized, crossover study of posaconazole administered via nasogastric tube in healthy volunteers...
Pharmacokinetics and absorption of posaconazole oral suspension under various gastric conditions in healthy volunteers. [2009.03]
A four-part, randomized, crossover study with healthy subjects evaluated the effects of gastric pH, the dosing frequency and prandial state, food consumption timing, and gastric motility on the absorption of posaconazole. In part 1, a single dose (SD) of posaconazole (400 mg) was administered alone or with an acidic beverage or a proton pump inhibitor (PPI), or both...
Effects of oral posaconazole on the pharmacokinetic properties of oral and intravenous midazolam: a phase I, randomized, open-label, crossover study in healthy volunteers. [2009.02]
BACKGROUND: Like itraconazole and ketoconazole, posaconazole, a broad-spectrum oral triazole antifungal, inhibits the activity of the cytochrome P450 (CYP) isozyme 3A4. Midazolam, a short-acting benzodiazepine, is metabolized by CYP3A4. Potential drug interactions can be expected in patients who are concurrently receiving inhibitors and substrates of CYP3A4 (eg, ketoconazole, posaconazole) and benzodiazepines (eg, midazolam). Because of the potential for drug interactions, it is important to determine the effects of posaconazole on the pharmacokinetic properties of midazolam. OBJECTIVE: The aim of this study was to compare the effects of oral administration of posaconazole versus ketoconazole on the pharmacokinetic properties of orally and intravenously administered midazolam... CONCLUSIONS: The results from this study in a small, all-white population of healthy volunteers suggest that posaconazole was a potent inhibitor of CYP3A4, but to a lesser extent than was ketoconazole. Monitoring patients for adverse events, the need for dose adjustments, or both during coadministration with posaconazole may be warranted in patients being treated with benzodiazepines that are predominantly metabolized through CYP3A4 (eg, midazolam).
Intrapulmonary pharmacokinetics and pharmacodynamics of posaconazole at steady state in healthy subjects. [2009.02]
We evaluated the pharmacokinetics (PK) and pharmacodynamics (PD) of posaconazole (POS) in a prospective, open-label study. Twenty-five healthy adults received 14 doses of POS oral suspension (400 mg twice daily) with a high-fat meal over 8 days... The intrapulmonary PK/PD of POS are favorable for treatment or prevention of aspergillosis, and oral POS was well tolerated in healthy adults.
Clinical Trials Related to Noxafil (Posaconazole)
A Study to Evaluate Efficacy and Safety of Four Posaconazole Regimens With Placebo and Terbinafine in the Treatment of Toenail Onychomycosis (Study P05082AM2) [Active, not recruiting]
Limited Access Protocol of Posaconazole in Invasive Fungal Infections Study PO2095 [Terminated]
Therapeutic options for serious fungal infections are limited by intrinsic and acquired
resistance to existing antifungal agents. For example, zygomycetes (such as Mucor spp.) are
intrinsically resistant to voriconazole and caspofungin. Yet, the only available therapeutic
option, amphotericin, is associated with significant renal toxicity, even in lipid
formulations. Posaconazole is a new antifungal drug, not yet Food and Drug Administration
(FDA) approved, but which has excellent in vitro activity against some intrinsically
resistant fungi such as the zygomycetes.
The intent of this trial is to provide access to posaconazole to patients with serious fungal
infections which are refractory to standard antifungal therapies or invasive fungal
infections for which there are currently no effective therapies. Secondly, the drug will
also be made available to patients with invasive fungal infections who:
- have experienced serious or severe toxicities while receiving standard antifungal
therapies;
- have pre-existing renal dysfunction which precludes use of standard antifungal
therapies; or
- are chronically immunosuppressed with a history of invasive fungal infections previously
treated with posaconazole in other clinical trials, and who require oral antifungal
suppressive therapy as maintenance treatment to prevent recurrence.
This is a multicenter, open-label, non-comparative experimental treatment use protocol. The
experimental treatment use protocol will provide the investigational medication posaconazole
where no other drug is commercially available. Posaconazole is given as an orally or
enterally administered suspension. The duration of therapy is at the discretion of the
investigator. Safety assessments will include an electrocardiogram [ECG] (to ensure no QTc
interval prolongation) performed at baseline and serum/urine pregnancy testing performed at
baseline and every three months after initiation of therapy. Plasma concentrations will be
obtained if there is evidence of clinical failure. No other tests will be performed
specifically for the experimental treatment use protocol.
Postmarketing Surveillance Study on the Labeled Use of Oral Posaconazole 40 mg/mL Suspension (Study P04641) [Recruiting]
Oral Posaconazole Three Times Per Day vs Weekly High Dose Amphotericin B Lipid Complex (ABLC) [Recruiting]
The objective of this study is to compare the safety and efficacy of ABLC versus oral
Posaconazole in the prevention of invasive fungal infections in high risk patients with
hematologic malignancies or hematopoietic stem cell transplant.
Pharmacokinetics of Posaconazole Prophylaxis in Acute Leukemia [Recruiting]
The goal of this clinical research study is to learn the amount of posaconazole that is in
the body at different time points when given to patients with leukemia. The safety of this
drug will also be studied.
Primary Objectives:
To study the plasma pharmacokinetics of posaconazole in relapsed or refractory patients with
AML or HR-MDS who will receive salvage chemotherapy.
Secondary Objectives:
To evaluate the safety of posaconazole given as prophylaxis in relapsed or refractory
patients with acute leukemia who will receive salvage chemotherapy.
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