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Completed

NCT Number: NCT00686543

Oral Posaconazole in High Risk Patients With Gastrointestinal Dysfunction (Study P05115)

The purpose of this study is: to explore the potential for different dosing strategies of posaconazole oral suspension (POS) to increase plasma levels and to profile the pharmacokinetics of these dosing strategies in patients with compromised gastrointestinal function and at high risk for Invasive Fungal Infection.

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Key information

Conditions

Fungal Infection Acute Myelogenous Leukemia Agranulocytosis Bacterial Infections and Mycoses Cytopenia Hematologic Diseases Hemic and Lymphatic Diseases Infections Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Leukocyte Disorders Leukopenia Mycoses Neoplasms Neoplasms by Histologic Type Neutropenia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects >=18 years of age
  • High risk of poor enteral medication absorption, based on the effects of cytotoxic chemotherapy, as evidenced by, but not limited to, mucositis, nausea, vomiting, and diarrhea, at baseline.
  • High risk of invasive fungal infection (IFI) based on anticipated or documented prolonged neutropenia (absolute neutrophil count [ANC] <500/mm^3 [0.5 x 10^9/L]).
  • Clinical laboratory safety tests within normal limits or clinically acceptable to the investigator or sponsor.
  • Free of any clinically significant disease (other than the primary hematologic disease) that would interfere with the study evaluations.
  • Subjects must be willing to give written informed consent and able to adhere to dosing, study visit schedule, and mandatory procedures.

Exclusion criteria

  • Female subjects who are pregnant, intend to become pregnant, or are nursing.
  • Excluded prior treatments. Subjects receiving systemic antifungal therapy (oral, intravenous, or inhaled) for the treatment of proven or probable IFI within 30 days of Enrollment (ie, voriconazole, fluconazole [FLU], or itraconazole [ITZ]).
  • Subjects receiving posaconazole for prophylaxis against IFI 10 days prior to enrollment. (Subjects who are receiving either voriconazole or micafungin for prophylaxis against IFI should discontinue those therapies upon enrollment.)
  • Subjects with moderate or severe liver dysfunction at Baseline, defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels greater than two times the upper limit of normal (ULN), or a total bilirubin level greater than two times the ULN.
  • Subjects who have taken prohibited medications more recently than the indicated washout period prior to Enrollment.
  • Subjects who must take prohibited medications during the study.
  • Subjects who are in a situation or have any condition that, in the opinion of the investigator, may interfere with optimal participation in the study.
  • Subjects who have used any investigational drugs or biologic agents other than their chemotherapy regimens within 30 days of study entry.
  • Subjects who are part of the staff personnel directly involved with this study.
  • Subjects who are a family member of the investigational study staff.
  • Prior enrollment in this study.
  • Subjects with a history of hypersensitivity or idiosyncratic reactions to azole agents.
  • Subjects with Eastern Cooperative Oncology Group (ECOG) performance status >2 prior to induction chemotherapy for their underlying disease.
  • Subjects with proven or probable invasive or systemic fungal infection at Baseline.
  • Subjects with a history of acute lymphoblastic leukemia or chronic myelogenous leukemia without blast crisis.

Treatment and study plan

Posaconazole

Drug

Posaconazole will be used for prophylaxis

Other names: SCH 056592 - NOXAFIL®

Primary outcomes

  1. Mean POS Plasma Concentrations on Days 2, 3, and 8.

    Time frame: Predose (0 hour) and 5 hours postdose on Days 2, 3, and 8

    Individual mean concentrations were calculated as the average of observed concentrations at 0 hour (before the morning dose) and 5 hours after the morning dose.

  2. Mean POS Plasma Concentrations on Days 8 and 15 Stratified by Randomized Dosing Regimen

    Time frame: Predose (0 hour) and 5 hours postdose on Days 8 and 15

    Individual mean concentrations were calculated as the average of observed concentrations at 0 hour (before the morning dose) and 5 hours after the morning dose.

  3. Participants With a Mean POS Plasma Concentration ≥/<250 ng/mL on Day 3 and ≥/<500 ng/mL on Day 8

    Time frame: Predose (0 hour) and 5 hours postdose on Days 3 and 8

    Individual mean concentrations were calculated as the average of observed concentrations at 0 hour (before the morning dose) and 5 hours after the morning dose.

  4. Participants With a Mean POS Plasma Concentration ≥/<350 ng/mL on Day 3 and ≥/<700 ng/mL on Day 8

    Time frame: Predose (0 hour) and 5 hours postdose on Days 3 and 8

    Individual mean concentrations were calculated as the average of observed concentrations at 0 hour (before the morning dose) and 5 hours after the morning dose.

  5. Participants With a Mean POS Plasma Concentration ≥/<250 ng/mL on Day 8 and ≥/<500 ng/mL on Day 15

    Time frame: Predose (0 hour) and 5 hours postdose on Days 8 and 15

    Individual mean concentrations calculated as the average of observed concentrations at 0 hour (before the morning dose) and 5 hours after the morning dose.

  6. Participants With a Mean POS Plasma Concentration ≥/<350 ng/mL on Day 8 and ≥/<700 ng/mL on Day 15

    Time frame: Predose (0 hour) and 5 hours postdose on Days 8 and 15

    Individual mean concentrations were calculated as the average of observed concentrations at 0 hour (before the morning dose) and 5 hours after the morning dose.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Phase 4 Study of the Pharmacokinetics of Oral Posaconazole (SCH 56592) Among Patients With Compromised Gastrointestinal Function and at High Risk for Invasive Fungal Infection

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
May 30, 2008
Registry last updated
Apr 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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