Trials / Terminated
TerminatedNCT01716234
A Study of the Safety, Tolerance, and Pharmacokinetics of Oral Posaconazole in Immunocompromised Children (P03579)
Phase 1B Study of the Safety, Tolerance, and Pharmacokinetics of Oral Posaconazole in Immunocompromised Children With Neutropenia (P03579)
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 142 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 3 Months – 17 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Posaconazole 12 mg/kg/day BID | Posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) (maximum 800 mg/day) |
| DRUG | Posaconazole 18 mg/kg/day BID | Posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) (maximum 1200 mg/day) |
| DRUG | Posaconazole 18 mg/kg/day TID | Posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) (maximum 1200 mg/day) |
| DRUG | Posaconazole 12 mg/kg/day TID | Posaconazole oral suspension 12 mg/kg/day divided into 3 doses (TID) (maximum 800 mg/day) |
Timeline
- Start date
- 2008-04-17
- Primary completion
- 2015-04-01
- Completion
- 2015-04-01
- First posted
- 2012-10-29
- Last updated
- 2018-08-27
- Results posted
- 2016-04-15
Source: ClinicalTrials.gov record NCT01716234. Inclusion in this directory is not an endorsement.