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

Fungal Infections Clinical Trial

Official title:

Phase 1B Study of the Safety, Tolerance, and Pharmacokinetics of Oral Posaconazole in Immunocompromised Children With Neutropenia (P03579)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01716234
• Other study ID #: P03579
• Secondary ID: 2007-004645-15MK
• Status: Terminated
• Phase: Phase 1
• Start date: April 17, 2008
• Est. completion date: April 1, 2015

Study information

• Verified date: July 2018
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 142
• Est. completion date: April 1, 2015
• Est. primary completion date: April 1, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Months to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Fungal Infections
• Mycoses

Intervention

Drug:
• Posaconazole 12 mg/kg/day BID
Posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) (maximum 800 mg/day)
• Posaconazole 18 mg/kg/day BID
Posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) (maximum 1200 mg/day)
• Posaconazole 18 mg/kg/day TID
Posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) (maximum 1200 mg/day)
• Posaconazole 12 mg/kg/day TID
Posaconazole oral suspension 12 mg/kg/day divided into 3 doses (TID) (maximum 800 mg/day)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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)
Primary	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.	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	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.	Up to Day 58
Secondary	Number of Participants With an Adverse Event Leading to Study Drug Discontinuation	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.	Up to Day 28