Clinical trial NCT01425190: Pharmacokinetics of Boceprevir in Pediatric Subjects With Chronic Hepatitis C Genotype 1 (P07614)
Official title: Assessment of the Pharmacokinetics of Boceprevir in Pediatric Subjects With Chronic Hepatitis C Genotype 1 (Phase 1b); Protocol No. P07614
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Hepatitis C, Chronic
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2011-08-29
Enrollment: 16
Sex: ALL
Minimum age (years): 3
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Documented chronic hepatitis C (CHC) genotype 1 infection
* Treatment naïve or failed previous interferon/ribavirin therapy (≥12 uninterrupted weeks)
* Weigh between 10 kg to 90 kg inclusive at screening and baseline (Day -1).
* Body Mass Index (BMI) from the 5th to the 95th percentile for the participant's age and gender, inclusive, per tables from the Center for Disease Control and Prevention, USA
* Use of acceptable methods of contraception for at least 3 months prior to baseline and continue on study

Exclusion Criteria:

* Co-infection with the human immunodeficiency virus (HIV) or hepatitis B virus (HBsAg positive).
* Treatment with ribavirin within 90 days, or any interferon-alfa within 30 days
* Discontinued from interferon treatment due to adverse events
* Currently receiving antiviral/immunomodulating therapy for hepatitis C
* Prior treatment with an HCV protease inhibitor
* Prior treatment with any known hepatotoxic agent (including herbal remedies)
* Use of investigational drugs within 30 days of enrollment into study
* Evidence of de-compensated liver disease including, but not limited to, a history or presence of clinical ascites, bleeding varices, or hepatic encephalopathy.
* Substance abuse (including but not limited to alcohol abuse, illicit drugs,

inhalational drugs, marijuana use, etc) any time prior to entry into the study

* Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of any drug.
* Pregnant or breastfeeding female
* Meeting any of the laboratory exclusion criteria

Primary outcomes:
measure: Area Under the Plasma Concentration Time Curve (AUC) From 0-Infinity of Single Dose Boceprevir
timeFrame: 0 (pre-dose), 0.5, 1, 2, 2.5, 4.5, 5.5, 8, and 10 hours post dose
measure: Maximum Plasma Concentration (Cmax) of Single Dose Boceprevir
timeFrame: 0 (pre-dose), 0.5, 1, 2, 2.5, 4.5, 5.5, 8, and 10 hours post dose
measure: Time of Maximum Plasma Concentration (Tmax) of Single Dose Boceprevir
timeFrame: 0 (pre-dose), 0.5, 1, 2, 2.5, 4.5, 5.5, 8, and 10 hours post dose
measure: Final Dose of Boceprevir By Age Group
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: