Safety and Pharmacokinetics of Intravenous and Oral Posaconazole in Immunocompromised Children (MK-5592-097)

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02452034
• Date of registration: 20/05/2015
• Prospective Registration: Yes
• Primary sponsor: Merck Sharp & Dohme Corp.
• Public title: Safety and Pharmacokinetics of Intravenous and Oral Posaconazole in Immunocompromised Children (MK-5592-097)
• Scientific title: A Study of the Safety, Tolerability, and Pharmacokinetics of Intravenous (IV) and Powder for Oral Suspension Formulations of Posaconazole (POS) in Immunocompromised Pediatric Subjects With Neutropenia
• Date of first enrolment: September 7, 2015
• Target sample size: 118
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02452034
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

Belgium, Czech Republic, Czechia, Denmark, Germany, Guatemala, Italy, Norway, Spain, Sweden, Thailand, United States

Contacts

• Name: Medical Director
• Affiliation: Merck Sharp & Dohme Corp.

Key inclusion & exclusion 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 <30 mL/min.

- Has QTc (QT interval corrected for rate) prolongation defined as: a) Symptomatic QTc
prolongation >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



Age minimum: 2 Years
Age maximum: 17 Years
Gender: All

Health Condition(s) or Problem(s) studied

Neutropenia

Intervention(s)

Drug: Posaconazole IV solution

Drug: Posaconazole powder for oral suspension

Primary Outcome(s)

Average Steady-state Plasma Concentration (Cavg) for POS [Time Frame: Any day from Day 7 to Day 10 of therapy for each formulation (up to 28 days) at pre-dose, within 15 minutes after end of infusion (up to 2 hours), and 4, 6, 8, 12, 24 hours post-infusion]

Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to 24 Hours Post-dose for POS [Time Frame: Any day from Day 7 to Day 10 of therapy for each formulation (up to 28 days) at pre-dose, within 15 minutes after end of infusion (up to 2 hours), and 4, 6, 8, 12, 24 hours post-infusion]

Minimum Plasma Concentration (Cmin) for POS [Time Frame: Any day from Day 7 to Day 10 of therapy for each formulation (up to 28 days) at pre-dose, within 15 minutes after end of infusion (up to 2 hours), and 4, 6, 8, 12, 24 hours post-infusion]

Maximum Plasma Concentration (Cmax) for POS [Time Frame: Any day from Day 7 to Day 10 of therapy for each formulation (up to 28 days) at pre-dose, within 15 minutes after end of infusion (up to 2 hours), and 4, 6, 8, 12, 24 hours post-infusion]

Time of Maximum Plasma Concentration (Tmax) for POS [Time Frame: Any day from Day 7 to Day 10 of therapy for each formulation (up to 28 days) at pre-dose, within 15 minutes after end of infusion (up to 2 hours), and 4, 6, 8, 12, 24 hours post-infusion]

Apparent Total Body Clearance (CL/F) for POS Administered by PFS [Time Frame: Any day from Day 7 to Day 10 of therapy (up to 28 days) at pre-dose, within 15 minutes after end of infusion (up to 2 hours), and 4, 6, 8, 12, 24 hours post-infusion]

Total Body Clearance (CL) for POS Administered by IV [Time Frame: Any day from Day 7 to Day 10 of therapy (up to 28 days) at pre-dose, within 15 minutes after end of infusion (up to 2 hours), and 4, 6, 8, 12, 24 hours post-infusion]

Secondary Outcome(s)

Number of Participants Who Discontinued Treatment of Study Drug Due to an Adverse Event (AE) [Time Frame: Up to 28 days]

Number of Participants With an Adverse Event (AE) [Time Frame: 14 days after end of treatment (Up to 42 days)]

Secondary ID(s)

2014-002807-10

5592-097

MK-5592-097

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 26/07/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02452034