Phase 1
Completed N=118
Safety and Pharmacokinetics of Intravenous and Oral Posaconazole in Immunocompromised Children (MK-5592-097)
Source: ClinicalTrials.gov NCT02452034 ↗Enrolled (actual)
118
Serious AEs
27.0%
Results posted
Jul 2019
Primary outcomePrimary: Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to 24 Hours Post-dose for POS — 17800; 27300; 25600; 29800 hr*ng/mL
Summary
This study aims to evaluate the pharmacokinetics of posaconazole (POS) administered intravenously (IV) or orally to immunocompromised pediatric participants.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to 24 Hours Post-dose for POS |
17800; 27300; 25600; 29800; 31100; 44200 | — |
| PRIMARY Maximum Plasma Concentration (Cmax) for POS |
1590; 2450; 2320; 2310; 3060; 3340 | — |
| PRIMARY Minimum Plasma Concentration (Cmin) for POS |
400; 670; 501; 737; 626; 1160 | — |
| PRIMARY Average Steady-state Plasma Concentration (Cavg) for POS |
743; 1140; 1070; 1240; 1300; 1840 | — |
| PRIMARY Time of Maximum Plasma Concentration (Tmax) for POS |
1.78; 1.77; 1.78; 1.75; 1.75; 1.77 | — |
| PRIMARY Total Body Clearance (CL) for POS Administered by IV |
3.39; 6.64; 2.97; 6.69; 3.27; 4.76 | — |
| PRIMARY Apparent Total Body Clearance (CL/F) for POS Administered by PFS |
4.97; 7.67; 3.49; 7.84; 4.60; 8.39 | — |
| SECONDARY Number of Participants With an Adverse Event (AE) |
13; 21; 15; 16; 19; 29 | — |
| SECONDARY Number of Participants Who Discontinued Treatment of Study Drug Due to an Adverse Event (AE) |
3; 3; 0; 2; 4; 6 | — |
Eligibility Criteria
Inclusion Criteria
- Have documented or anticipated neutropenia expected to last for at least 7 days, following treatment in at least one of the following clinical situations: acute leukemia, myelodysplasia, severe aplastic anemia, recipients of Autologous Hematopoietic Stem Cell Transplant (HSCT), high risk neuroblastoma, advanced stage non-Hodgkin's lymphoma, hemophagocytic lymphohistiocytosis
- Have a central line in place prior to IV study therapy
- Participants of reproductive potential agree to remain abstinent, or use a medically accepted method of birth control
Exclusion Criteria
- Has a proven or probable invasive fungal infection
- Has received any formulation of POS within prior 10 days
- Is receiving any prohibited drugs
- Has laboratory results that are outside of normal limits at screening, as follows: a) Moderate or severe liver dysfunction, as defined as: Aspartate Aminotransferase (AST) > 5 times the upper limit of normal (ULN), OR Alanine Aminotransferase (ALT) > 5 times the ULN, OR Serum total bilirubin >2.5 times the ULN, OR AST or ALT > 3 times ULN with total bilirubin > 2 times ULN; b) Calculated creatinine clearance 450 msec (males) or >470 msec (females) OR b) Any QTc prolongation of >500 msec
- Is pregnant, intends to become pregnant during study, or is breastfeeding
- Has a history of anaphylaxis attributed to the azole class of antifungal agents
- Is not expected to receive a minimum of 10 days of POS IV solution
- Has participated in any Phase 1 Investigational New Drug (IND) study within prior 30 days or expects to do so within the following 60 days
- Is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling or child) who is investigational site or sponsor staff directly involved with this trial
Data sourced from ClinicalTrials.gov (NCT02452034). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.