Trial Outcomes & Findings for Pharmacokinetics of Boceprevir in Pediatric Subjects With Chronic Hepatitis C Genotype 1 (P07614) (NCT NCT01425190)
NCT ID: NCT01425190
Last Updated: 2018-09-11
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
16 participants
Primary outcome timeframe
0 (pre-dose), 0.5, 1, 2, 2.5, 4.5, 5.5, 8, and 10 hours post dose
Results posted on
2018-09-11
Participant Flow
This study originally intended to enroll 3 age-based pediatric cohorts. However the study was terminated after the completion of Cohort 1. No participants were enrolled in either Cohorts 2 or 3. Only data from Cohort 1 was collected.
Participant milestones
| Measure |
Cohort 1: Children 17 to ≥13 Years
Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such pudding or applesauce. The first 4 participants were treated with a 11.4 mg/kg dose of boceprevir powder. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
|
Cohort 2: Children <13 to ≥7 Years
Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such as pudding or applesauce. The first 4 participants were treated with boceprevir at a dose contingent on the PK and safety results in Cohort 1. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
|
Cohort 3: Children <7 to ≥3 Years
Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such as pudding or applesauce. The first 4 participants were treated with boceprevir at a dose contingent on the PK and safety results in Cohort 2. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
|
|---|---|---|---|
|
Overall Study
STARTED
|
16
|
0
|
0
|
|
Overall Study
COMPLETED
|
15
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Cohort 1: Children 17 to ≥13 Years
Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such pudding or applesauce. The first 4 participants were treated with a 11.4 mg/kg dose of boceprevir powder. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
|
Cohort 2: Children <13 to ≥7 Years
Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such as pudding or applesauce. The first 4 participants were treated with boceprevir at a dose contingent on the PK and safety results in Cohort 1. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
|
Cohort 3: Children <7 to ≥3 Years
Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such as pudding or applesauce. The first 4 participants were treated with boceprevir at a dose contingent on the PK and safety results in Cohort 2. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
|
|---|---|---|---|
|
Overall Study
Full dose not consumed.
|
1
|
0
|
0
|
Baseline Characteristics
Pharmacokinetics of Boceprevir in Pediatric Subjects With Chronic Hepatitis C Genotype 1 (P07614)
Baseline characteristics by cohort
| Measure |
Cohort 1: Children 17 to ≥13 Years
n=16 Participants
Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such pudding or applesauce. The first 4 participants were treated with a 11.4 mg/kg dose of boceprevir powder. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
|
Cohort 2: Children <13 to ≥7 Years
Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such as pudding or applesauce. The first 4 participants were treated with boceprevir at a dose contingent on the PK and safety results in Cohort 1. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
|
Cohort 3: Children <7 to ≥3 Years
Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such as pudding or applesauce. The first 4 participants were treated with boceprevir at a dose contingent on the PK and safety results in Cohort 2. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
Age
|
14.9 Years
STANDARD_DEVIATION 1.2 • n=5 Participants
|
—
|
—
|
14.9 Years
STANDARD_DEVIATION 1.2 • n=4 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
—
|
—
|
7 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
—
|
—
|
9 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 0 (pre-dose), 0.5, 1, 2, 2.5, 4.5, 5.5, 8, and 10 hours post dosePopulation: The Per Protocol (PP) population includes all participants who complied with the protocol sufficiently to ensure that data for this assessment were likely to exhibit the effects of treatment, according to the underlying scientific model.
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.
Outcome measures
| Measure |
Cohort 1: Children 17 to ≥13 Years
n=14 Participants
Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such pudding or applesauce. The first 4 participants were treated with a 11.4 mg/kg dose of boceprevir powder. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
|
Cohort 2: Children <13 to ≥7 Years
Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such as pudding or applesauce. The first 4 participants were treated with boceprevir at a dose contingent on the PK and safety results in Cohort 1. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
|
Cohort 3: Children <7 to ≥3 Years
Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such as pudding or applesauce. The first 4 participants were treated with boceprevir at a dose contingent on the PK and safety results in Cohort 2. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
|
|---|---|---|---|
|
Area Under the Plasma Concentration Time Curve (AUC) From 0-Infinity of Single Dose Boceprevir
|
6660 ng hr/mL
Interval 3860.0 to 10500.0
|
—
|
—
|
PRIMARY outcome
Timeframe: 0 (pre-dose), 0.5, 1, 2, 2.5, 4.5, 5.5, 8, and 10 hours post dosePopulation: The Per Protocol (PP) population includes all participants who complied with the protocol sufficiently to ensure that data for this assessment were likely to exhibit the effects of treatment, according to the underlying scientific model.
The maximum observed plasma concentration of boceprevir across sampling intervals was determined.
Outcome measures
| Measure |
Cohort 1: Children 17 to ≥13 Years
n=15 Participants
Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such pudding or applesauce. The first 4 participants were treated with a 11.4 mg/kg dose of boceprevir powder. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
|
Cohort 2: Children <13 to ≥7 Years
Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such as pudding or applesauce. The first 4 participants were treated with boceprevir at a dose contingent on the PK and safety results in Cohort 1. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
|
Cohort 3: Children <7 to ≥3 Years
Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such as pudding or applesauce. The first 4 participants were treated with boceprevir at a dose contingent on the PK and safety results in Cohort 2. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
|
|---|---|---|---|
|
Maximum Plasma Concentration (Cmax) of Single Dose Boceprevir
|
1710 ng/mL
Interval 985.0 to 2320.0
|
—
|
—
|
PRIMARY outcome
Timeframe: 0 (pre-dose), 0.5, 1, 2, 2.5, 4.5, 5.5, 8, and 10 hours post dosePopulation: The Per Protocol (PP) population includes all participants who complied with the protocol sufficiently to ensure that data for this assessment were likely to exhibit the effects of treatment, according to the underlying scientific model.
The time at which the maximum plasma boceprevir concentration was observed.
Outcome measures
| Measure |
Cohort 1: Children 17 to ≥13 Years
n=15 Participants
Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such pudding or applesauce. The first 4 participants were treated with a 11.4 mg/kg dose of boceprevir powder. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
|
Cohort 2: Children <13 to ≥7 Years
Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such as pudding or applesauce. The first 4 participants were treated with boceprevir at a dose contingent on the PK and safety results in Cohort 1. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
|
Cohort 3: Children <7 to ≥3 Years
Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such as pudding or applesauce. The first 4 participants were treated with boceprevir at a dose contingent on the PK and safety results in Cohort 2. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
|
|---|---|---|---|
|
Time of Maximum Plasma Concentration (Tmax) of Single Dose Boceprevir
|
1.87 Hour
Interval 0.4 to 4.5
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1Population: This outcome measure could not be analyzed due to termination of the study prior to enrolling Cohorts 2 and 3.
Outcome measures
Outcome data not reported
Adverse Events
Cohort 1: Children 17 to ≥13 Years
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Cohort 2: Children <13 to ≥7 Years
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 3: Children <7 to ≥3 Years
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1: Children 17 to ≥13 Years
n=16 participants at risk
Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such pudding or applesauce. The first 4 participants were treated with a 11.4 mg/kg dose of boceprevir powder. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
|
Cohort 2: Children <13 to ≥7 Years
Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such as pudding or applesauce. The first 4 participants were treated with boceprevir at a dose contingent on the PK and safety results in Cohort 1. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
|
Cohort 3: Children <7 to ≥3 Years
Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such as pudding or applesauce. The first 4 participants were treated with boceprevir at a dose contingent on the PK and safety results in Cohort 2. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
|
|---|---|---|---|
|
Investigations
Alanine aminotransferase increased
|
6.2%
1/16 • Number of events 1 • Nonserious adverse events (AEs) and serious AEs (SAEs) were collected during the time of boceprevir administration until the final PK sample was collected on Day 1.
AEs were monitored in the All Subjects as Treated (all boceprevir-treated participants) population.
|
—
0/0 • Nonserious adverse events (AEs) and serious AEs (SAEs) were collected during the time of boceprevir administration until the final PK sample was collected on Day 1.
AEs were monitored in the All Subjects as Treated (all boceprevir-treated participants) population.
|
—
0/0 • Nonserious adverse events (AEs) and serious AEs (SAEs) were collected during the time of boceprevir administration until the final PK sample was collected on Day 1.
AEs were monitored in the All Subjects as Treated (all boceprevir-treated participants) population.
|
|
Investigations
Liver function test abnormal
|
6.2%
1/16 • Number of events 1 • Nonserious adverse events (AEs) and serious AEs (SAEs) were collected during the time of boceprevir administration until the final PK sample was collected on Day 1.
AEs were monitored in the All Subjects as Treated (all boceprevir-treated participants) population.
|
—
0/0 • Nonserious adverse events (AEs) and serious AEs (SAEs) were collected during the time of boceprevir administration until the final PK sample was collected on Day 1.
AEs were monitored in the All Subjects as Treated (all boceprevir-treated participants) population.
|
—
0/0 • Nonserious adverse events (AEs) and serious AEs (SAEs) were collected during the time of boceprevir administration until the final PK sample was collected on Day 1.
AEs were monitored in the All Subjects as Treated (all boceprevir-treated participants) population.
|
Other adverse events
| Measure |
Cohort 1: Children 17 to ≥13 Years
n=16 participants at risk
Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such pudding or applesauce. The first 4 participants were treated with a 11.4 mg/kg dose of boceprevir powder. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
|
Cohort 2: Children <13 to ≥7 Years
Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such as pudding or applesauce. The first 4 participants were treated with boceprevir at a dose contingent on the PK and safety results in Cohort 1. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
|
Cohort 3: Children <7 to ≥3 Years
Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such as pudding or applesauce. The first 4 participants were treated with boceprevir at a dose contingent on the PK and safety results in Cohort 2. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
12.5%
2/16 • Number of events 2 • Nonserious adverse events (AEs) and serious AEs (SAEs) were collected during the time of boceprevir administration until the final PK sample was collected on Day 1.
AEs were monitored in the All Subjects as Treated (all boceprevir-treated participants) population.
|
—
0/0 • Nonserious adverse events (AEs) and serious AEs (SAEs) were collected during the time of boceprevir administration until the final PK sample was collected on Day 1.
AEs were monitored in the All Subjects as Treated (all boceprevir-treated participants) population.
|
—
0/0 • Nonserious adverse events (AEs) and serious AEs (SAEs) were collected during the time of boceprevir administration until the final PK sample was collected on Day 1.
AEs were monitored in the All Subjects as Treated (all boceprevir-treated participants) population.
|
|
General disorders
Asthenia
|
6.2%
1/16 • Number of events 1 • Nonserious adverse events (AEs) and serious AEs (SAEs) were collected during the time of boceprevir administration until the final PK sample was collected on Day 1.
AEs were monitored in the All Subjects as Treated (all boceprevir-treated participants) population.
|
—
0/0 • Nonserious adverse events (AEs) and serious AEs (SAEs) were collected during the time of boceprevir administration until the final PK sample was collected on Day 1.
AEs were monitored in the All Subjects as Treated (all boceprevir-treated participants) population.
|
—
0/0 • Nonserious adverse events (AEs) and serious AEs (SAEs) were collected during the time of boceprevir administration until the final PK sample was collected on Day 1.
AEs were monitored in the All Subjects as Treated (all boceprevir-treated participants) population.
|
|
General disorders
Malaise
|
6.2%
1/16 • Number of events 1 • Nonserious adverse events (AEs) and serious AEs (SAEs) were collected during the time of boceprevir administration until the final PK sample was collected on Day 1.
AEs were monitored in the All Subjects as Treated (all boceprevir-treated participants) population.
|
—
0/0 • Nonserious adverse events (AEs) and serious AEs (SAEs) were collected during the time of boceprevir administration until the final PK sample was collected on Day 1.
AEs were monitored in the All Subjects as Treated (all boceprevir-treated participants) population.
|
—
0/0 • Nonserious adverse events (AEs) and serious AEs (SAEs) were collected during the time of boceprevir administration until the final PK sample was collected on Day 1.
AEs were monitored in the All Subjects as Treated (all boceprevir-treated participants) population.
|
|
Investigations
Blood pressure systolic increased
|
6.2%
1/16 • Number of events 1 • Nonserious adverse events (AEs) and serious AEs (SAEs) were collected during the time of boceprevir administration until the final PK sample was collected on Day 1.
AEs were monitored in the All Subjects as Treated (all boceprevir-treated participants) population.
|
—
0/0 • Nonserious adverse events (AEs) and serious AEs (SAEs) were collected during the time of boceprevir administration until the final PK sample was collected on Day 1.
AEs were monitored in the All Subjects as Treated (all boceprevir-treated participants) population.
|
—
0/0 • Nonserious adverse events (AEs) and serious AEs (SAEs) were collected during the time of boceprevir administration until the final PK sample was collected on Day 1.
AEs were monitored in the All Subjects as Treated (all boceprevir-treated participants) population.
|
|
Investigations
Hepatic enzyme increased
|
6.2%
1/16 • Number of events 1 • Nonserious adverse events (AEs) and serious AEs (SAEs) were collected during the time of boceprevir administration until the final PK sample was collected on Day 1.
AEs were monitored in the All Subjects as Treated (all boceprevir-treated participants) population.
|
—
0/0 • Nonserious adverse events (AEs) and serious AEs (SAEs) were collected during the time of boceprevir administration until the final PK sample was collected on Day 1.
AEs were monitored in the All Subjects as Treated (all boceprevir-treated participants) population.
|
—
0/0 • Nonserious adverse events (AEs) and serious AEs (SAEs) were collected during the time of boceprevir administration until the final PK sample was collected on Day 1.
AEs were monitored in the All Subjects as Treated (all boceprevir-treated participants) population.
|
|
Nervous system disorders
Dysgeusia
|
6.2%
1/16 • Number of events 1 • Nonserious adverse events (AEs) and serious AEs (SAEs) were collected during the time of boceprevir administration until the final PK sample was collected on Day 1.
AEs were monitored in the All Subjects as Treated (all boceprevir-treated participants) population.
|
—
0/0 • Nonserious adverse events (AEs) and serious AEs (SAEs) were collected during the time of boceprevir administration until the final PK sample was collected on Day 1.
AEs were monitored in the All Subjects as Treated (all boceprevir-treated participants) population.
|
—
0/0 • Nonserious adverse events (AEs) and serious AEs (SAEs) were collected during the time of boceprevir administration until the final PK sample was collected on Day 1.
AEs were monitored in the All Subjects as Treated (all boceprevir-treated participants) population.
|
|
Nervous system disorders
Syncope
|
18.8%
3/16 • Number of events 3 • Nonserious adverse events (AEs) and serious AEs (SAEs) were collected during the time of boceprevir administration until the final PK sample was collected on Day 1.
AEs were monitored in the All Subjects as Treated (all boceprevir-treated participants) population.
|
—
0/0 • Nonserious adverse events (AEs) and serious AEs (SAEs) were collected during the time of boceprevir administration until the final PK sample was collected on Day 1.
AEs were monitored in the All Subjects as Treated (all boceprevir-treated participants) population.
|
—
0/0 • Nonserious adverse events (AEs) and serious AEs (SAEs) were collected during the time of boceprevir administration until the final PK sample was collected on Day 1.
AEs were monitored in the All Subjects as Treated (all boceprevir-treated participants) population.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The investigator agrees not to publish or publicly present any interim results of the trial without the prior written consent of the sponsor. The investigator further agrees to provide to the sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication.
- Publication restrictions are in place
Restriction type: OTHER