A Study of the Safety, Tolerance, and Pharmacokinetics of Oral Posaconazole in Immunocompromised Children (P03579)

Phase 1TerminatedNCT01716234

Merck Sharp & Dohme LLC142 enrolled

Overview

The purpose of this dose-escalation study is to evaluate the pharmacokinetics, safety, and tolerability of oral posaconazole in immunocompromised children with neutropenia or expected neutropenia.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

142

Conditions

Fungal Infections

Interventions

Posaconazole 12 mg/kg/day BIDDRUG

Posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) (maximum 800 mg/day)

Posaconazole 18 mg/kg/day BIDDRUG

Posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) (maximum 1200 mg/day)

Posaconazole 18 mg/kg/day TIDDRUG

Posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) (maximum 1200 mg/day)

Eligibility

Sex: ALLMin age: 3 MonthsMax age: 17 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Documented or anticipated neutropenia expected to last at least 7 days and only in the following clinical situations: acute leukemia; myelodysplasia; severe aplastic anemia; autologous hematopoietic stem cell transplantation (HSCT) recipients; high risk neuroblastoma; advanced stage non-Hodgkin's lymphoma; recipients of allogeneic HSCT during the pre-engraftment (neutropenia) period * Participants of child-bearing potential must use a medically accepted method of contraception throughout the study and for at least 30 days after stopping study medication, unless they are surgically or medically sterile or agree to remain abstinent. Exclusion Criteria: * Proven invasive fungal infection (IFI) before study entry * Severe nausea and/or vomiting at screening * Received posaconazole within 10 days before screening * Unable to receive study drug by mouth or via an intestinal (enteral) tube * Females who are pregnant, intend to become pregnant during the study, or are breastfeeding * History of anaphylaxis attributed to the azole class of antifungal agents

Outcomes

Primary Outcomes

Average Concentration of Posaconazole (Cavg) on Day 1 (Single Dose)

Blood samples for determination of plasma posaconazole concentration were collected predose and approximately 3, 5, 8, and 12 hours after the first dose on Day 1. The 12-hour sample was not obtained for the TID dose groups. Day 1 pharmacokinetic samples were not collected for participants 3 months to \<2 years of age weighing \<6.5 kg.

Time frame: Up to 12 hours after the first dose (BID dose groups) or up to 8 hours after the first dose (TID dose (TID dose groups)

Average Concentration of Posaconazole (Cavg) on Day 7 (Steady State)

Blood samples for determination of plasma posaconazole concentration were collected predose and approximately 3, 5, 8, and 12 hours after the first dose on Day 7 (steady state). The 12-hour sample was not obtained for the TID dose groups. The target Cavg range was 500 to \<2500 ng/mL.

Time frame: Up to 12 hours after the first dose on Day 7 (BID dose groups) or up to 8 hours after the first dose on Day 7 (TID dose

Secondary Outcomes

Number of Participants With an Adverse Event

An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product, biologic (at any dose), or medical device, which does not necessarily have a causal relationship with the treatment. Adverse events may include the onset of new illness and the exacerbation of preexisting conditions.

Time frame: Up to Day 58

Number of Participants With an Adverse Event Leading to Study Drug Discontinuation

Time frame: Up to Day 28

Data from ClinicalTrials.gov

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