treatment and prophylaxis of invasive fungal infections
Conditions
Interventions
Trade Name: NOXAFIL
Pharmaceutical Form: Oral suspension
INN or Proposed INN: Posaconazole
Concentration unit: mg/ml milligram(s)/millilitre
Sponsors
Schering Plough Research Institute
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: . Children of either sex and of any race, 3 months to =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Subjects with proven IFI, as defined by the MSG/EORTC criteria prior to study entry. 2. Subjects with Grade 3 or Grade 4 nausea and/or vomiting at Screening. 3. Subjects receiving weekly vincristine. 4. Subjects receiving systemic antifungal other than POS (oral, non-absorbable antifungals are permitted). 5. Subjects who have received POS within the past 10 days prior to Screening. 6. Subjects receiving or planning to receive prohibited drugs during POS administration (please refer to Table 3). 7. Subjects whose laboratory tests are outside normal limits, as follows: a. AST or ALT >5 times the upper limit of normal (ULN) b. Serum total bilirubin >2.5 x ULN c. Calculated creatinine clearance 450 msec (males) or >470 msec (females) b. Any QTc prolongation of >500 msec 9. Subjects who are unable to receive study drug enterally. 10. Female subjects who are pregnant, intend to become pregnant during the course of the study, or are breast-feeding. 11. Subjects with a history of anaphylaxis attributed to the azole class of antifungal agents. 12. Subjects with any clinically significant condition or situation, other than the condition being studied that, in the opinion of the investigator, would interfere with the study evaluations or optimal participation in the study, including receiving less than 7 days of POS. 13. Subjects who have already participated in this study or are participating in any Phase 1 clinical study or any study for a medication that has not yet received regulatory approval. 14. Subjects who are part of the study staff personnel or family members of the study staff personnel
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate the pharmacokinetics (PK) of posaconazole (POS) administered orally at three dosage levels to immunocompromised children aged 3 months to <18 years with neutropenia or expected neutropenia;Secondary Objective: The secondary objective is to evaluate the safety and tolerability of POS administered orally at three dosage levels to immunocompromised children with neutropenia or expected neutropenia aged 3 months to <18 years and to compare the exposures to POS in pediatric subjects to those from an adult population with similar underlying conditions.;Primary end point(s): pharmacokinetics, safety and tollerance | — |
Countries
Germany, Greece, Italy, Netherlands
Outcome results
None listed