Trials / Terminated
TerminatedNCT01425190
Pharmacokinetics of Boceprevir in Pediatric Subjects With Chronic Hepatitis C Genotype 1 (P07614)
Assessment of the Pharmacokinetics of Boceprevir in Pediatric Subjects With Chronic Hepatitis C Genotype 1 (Phase 1b); Protocol No. P07614
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 16 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 3 Years – 17 Years
- Healthy volunteers
- Not accepted
Summary
This is a study to determine the pharmacokinetics (PK) and weight-based dose of boceprevir following single oral dose administration in Chronic Hepatitis C Virus (HCV) pediatric participants.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Boceprevir | Single dose of boceprevir powder prior to breakfast in a dosing vehicle of chocolate pudding (i.e., a mousse or custard), apple sauce, Nutella, fruit pudding such as strawberry, cherry, or raspberry pudding, or yogurt or a similar semi-solid product into which the boceprevir powder can be evenly stirred |
Timeline
- Start date
- 2012-01-04
- Primary completion
- 2013-03-20
- Completion
- 2013-03-20
- First posted
- 2011-08-29
- Last updated
- 2018-09-11
- Results posted
- 2014-10-08
Source: ClinicalTrials.gov record NCT01425190. Inclusion in this directory is not an endorsement.