Pharmacokinetics of Boceprevir in Pediatric Subjects With Chronic Hepatitis C Genotype 1 (P07614)

Hepatitis C, Chronic Clinical Trial

Official title:

Assessment of the Pharmacokinetics of Boceprevir in Pediatric Subjects With Chronic Hepatitis C Genotype 1 (Phase 1b); Protocol No. P07614

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01425190
• Other study ID #: P07614
• Secondary ID: 2010-023498-20MK
• Status: Terminated
• Phase: Phase 1
• Start date: January 4, 2012
• Est. completion date: March 20, 2013

Study information

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

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: March 20, 2013
• Est. primary completion date: March 20, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

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

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	Area Under the Plasma Concentration Time Curve (AUC) From 0-Infinity of Single Dose Boceprevir	Plasma concentrations of boceprevir were determined at 0 (pre-dose), 0.5, 1, 2, 2.5, 4.5, 5.5, 8, and 10 hours post dose.	0 (pre-dose), 0.5, 1, 2, 2.5, 4.5, 5.5, 8, and 10 hours post dose
Primary	Maximum Plasma Concentration (Cmax) of Single Dose Boceprevir	The maximum observed plasma concentration of boceprevir across sampling intervals was determined.	0 (pre-dose), 0.5, 1, 2, 2.5, 4.5, 5.5, 8, and 10 hours post dose
Primary	Time of Maximum Plasma Concentration (Tmax) of Single Dose Boceprevir	The time at which the maximum plasma boceprevir concentration was observed.	0 (pre-dose), 0.5, 1, 2, 2.5, 4.5, 5.5, 8, and 10 hours post dose
Primary	Final Dose of Boceprevir By Age Group		Day 1