A Phase 4 Study of the Pharmacokinetics of Oral Posaconazole Among Patients with Compromised Gastrointestinal Function and at High Risk for Invasive Fungal Infection. - N/A

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-003148-31-BE

Enrollment

Registered

2007-09-26

Start date

2007-10-12

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myeloid Leukemia, Neutropenia, Antifungal Prophylaxis, Gastrointestinal Disorders MedDRA version: 9.1 Level: LLT Classification code 10000880 Term: Acute myeloid leukaemia MedDRA version: 9.1 Level: LLT Classification code 10029354 Term: Neutropenia MedDRA version: 9.1 Level: LLT Classification code 10049085 Term: Antifungal prophylaxis MedDRA version: 9.1 Level: HLT Classification code 10017948 Term: Gastrointestinal disorders NEC

Interventions

Trade Name: Posaconazole SP 40 mg/ml oral suspension Pharmaceutical Form: Oral suspension INN or Proposed INN: Posaconazole CAS Number: 171228-49-2 Concentration unit: mg/ml milligram(s)/millilitre Co

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Basic demographics: Adult subjects (18 years or minimal age that defines an adult according to local regulations) of either sex or any race. 2. 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. 3. Subjects who are at high risk for IFI based on anticipated or documented prolonged neutropenia (ANC =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Female subjects who are pregnant, intend to become pregnant, or are nursing. 2. 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. 3. Subjects receiving posaconazole for prophylaxis against IFI within 10 days prior to enrollment. (Subjects who are receiving other systemic (oral, intravenous or inhaled) antifungal prophylaxis against IFI should discontinue those therapies upon enrollment.) 4. 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. 5. Excluded treatments prior to enrollment. Subjects who have taken prohibited medications more recently than the indicated washout period prior to Enrollment. 6. Excluded treatments during the study. Subjects who must take prohibited medications during the study. 7. 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 , ie, any condition requiring the use of prohibited drugs or unstable medical conditions other than the hematological disorder such as cardiac or neurologic disorder or impairment expected to be unstable or progressive during the course of this study (eg, seizures or demyelinating syndromes, acute myocardial infarction within 3 months of study entry, myocardial ischemia, or unstable congestive heart failure, unstable arrhythmias, atrial fibrillation with ventricular rate 2 prior to induction chemotherapy for their underlying disease. 14. Subjects with proven or provable invasive fungal infection, according to EORTC-MSG criteria (Appendix 3), at Baseline. 15. Subjects with a history of acute lymphoblastic leukemia or chronic myelogenous leukemia without blast crisis.

Design outcomes

Primary

Measure	Time frame
Main Objective: 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 a representative patient population with compromised gastrointestinal function and at high risk for Invasive Fungal infection (IFI).;Secondary Objective: To explore whether early measurement of plasma POS concentrations (prior to steady state) accurately predict steady state plasma concentrations in order to determine whether early plasma levels can be used to guide therapy to reach a desired threshold value at steady state.;Primary end point(s): The mean of plasma sample results (predose 0 hours and 5 hours after AM dose) for each patient from Days 2, 8 and 15 will be the primary endpoint for this study.	—

Measure

Time frame

Main Objective: 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 a representative patient population with compromised gastrointestinal function and at high risk for Invasive Fungal infection (IFI).;Secondary Objective: To explore whether early measurement of plasma POS concentrations (prior to steady state) accurately predict steady state plasma concentrations in order to determine whether early plasma levels can be used to guide therapy to reach a desired threshold value at steady state.;Primary end point(s): The mean of plasma sample results (predose 0 hours and 5 hours after AM dose) for each patient from Days 2, 8 and 15 will be the primary endpoint for this study.

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Countries

Belgium, Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026