A Phase 1 interventional study of Boceprevir in Hepatitis C, Chronic, sponsored by Merck Sharp & Dohme LLC. Terminated. Open to participants aged 3 Years to 17 Years. Per ClinicalTrials.gov, last updated 2018-09-11.
Sponsored by Merck Sharp & Dohme LLC (part of Merck & Co., Inc) · Phase 1, Interventional, and Treatment
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.
1,090 studies on the registry are indexed under Hepatitis C, Chronic; 9 are open to participants now.
This study's enrollment of 16 is below the median of 90 across 789 interventional studies indexed under Hepatitis C, Chronic.
Browse Hepatitis C, Chronic studies →Merck Sharp & Dohme LLC is the lead sponsor of 2,159 studies on the registry; 133 are open to participants now.
Of its 497 completed or terminated interventional studies of FDA-regulated products, 369 (74%) have results posted.
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Exclusion Criteria:
inhalational drugs, marijuana use, etc) any time prior to entry into the study
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.
Drug: Boceprevir
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.
Drug: Boceprevir
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.
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
Also known as: SCH 503034
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.
Time frame: 0 (pre-dose), 0.5, 1, 2, 2.5, 4.5, 5.5, 8, and 10 hours post dose
Maximum Plasma Concentration (Cmax) of Single Dose Boceprevir
The maximum observed plasma concentration of boceprevir across sampling intervals was determined.
Time frame: 0 (pre-dose), 0.5, 1, 2, 2.5, 4.5, 5.5, 8, and 10 hours post dose
Time of Maximum Plasma Concentration (Tmax) of Single Dose Boceprevir
The time at which the maximum plasma boceprevir concentration was observed.
Time frame: 0 (pre-dose), 0.5, 1, 2, 2.5, 4.5, 5.5, 8, and 10 hours post dose
Final Dose of Boceprevir By Age Group
Time frame: Day 1
| Milestone | Cohort 1: Children 17 to ≥13 Years | Cohort 2: Children <13 to ≥7 Years | Cohort 3: Children <7 to ≥3 Years |
|---|---|---|---|
| Started | 16 | 0 | 0 |
| Completed | 15 | 0 | 0 |
| Not completed | 1 | 0 | 0 |
| Withdrew: Full dose not consumed. | 1 | 0 | 0 |
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.
| ng hr/mL | Cohort 1: Children 17 to ≥13 Years | Cohort 2: Children <13 to ≥7 Years | Cohort 3: Children <7 to ≥3 Years |
|---|---|---|---|
| Area Under the Plasma Concentration Time Curve (AUC) From 0-Infinity of Single Dose Boceprevir | 6660 (3860 to 10500) | — | — |
The maximum observed plasma concentration of boceprevir across sampling intervals was determined.
| ng/mL | Cohort 1: Children 17 to ≥13 Years | Cohort 2: Children <13 to ≥7 Years | Cohort 3: Children <7 to ≥3 Years |
|---|---|---|---|
| Maximum Plasma Concentration (Cmax) of Single Dose Boceprevir | 1710 (985 to 2320) | — | — |
The time at which the maximum plasma boceprevir concentration was observed.
| Hour | Cohort 1: Children 17 to ≥13 Years | Cohort 2: Children <13 to ≥7 Years | Cohort 3: Children <7 to ≥3 Years |
|---|---|---|---|
| Time of Maximum Plasma Concentration (Tmax) of Single Dose Boceprevir | 1.87 (0.4 to 4.5) | — | — |
No measurements were reported for this outcome.
Collected over 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.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cohort 1: Children 17 to ≥13 Years | — | 1/16 (6.3%) | 6/16 (37.5%) |
| Cohort 2: Children <13 to ≥7 Years | — | — | — |
| Cohort 3: Children <7 to ≥3 Years | — | — | — |
| Event | Cohort 1: Children 17 to ≥13 Years | Cohort 2: Children <13 to ≥7 Years | Cohort 3: Children <7 to ≥3 Years |
|---|---|---|---|
| Alanine aminotransferase increasedInvestigations | 1/16 | — | — |
| Liver function test abnormalInvestigations | 1/16 | — | — |
| Event | Cohort 1: Children 17 to ≥13 Years | Cohort 2: Children <13 to ≥7 Years | Cohort 3: Children <7 to ≥3 Years |
|---|---|---|---|
| SyncopeNervous system disorders | 3/16 | — | — |
| NauseaGastrointestinal disorders | 2/16 | — | — |
| AstheniaGeneral disorders | 1/16 | — | — |
| MalaiseGeneral disorders | 1/16 | — | — |
| Blood pressure systolic increasedInvestigations | 1/16 | — | — |
| Hepatic enzyme increasedInvestigations | 1/16 | — | — |
| DysgeusiaNervous system disorders | 1/16 | — | — |
The Baseline Population includes all participants in Cohort 1 that received boceprevir. The trial was terminated prior to enrolling participants in either Cohorts 2 or 3.
| Age, Continuous(Years) | Cohort 1: Children 17 to ≥13 Years | Cohort 2: Children <13 to ≥7 Years | Cohort 3: Children <7 to ≥3 Years | Total |
|---|---|---|---|---|
| Age | 14.9 ± 1.2 | — | — | 14.9 ± 1.2 |
| Sex: Female, Male(Participants) | Cohort 1: Children 17 to ≥13 Years | Cohort 2: Children <13 to ≥7 Years | Cohort 3: Children <7 to ≥3 Years | Total |
|---|---|---|---|---|
| Female | 7 | — | — | 7 |
| Male | 9 | — | — | 9 |
No study locations are listed for this record.
Plan to share: Yes — https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
Data sharing details ↗ · engagezone.msd.com
No publications or documents are linked to this record.
Ran from Jan 2012 to primary completion in Mar 2013, 14 months.
Results were first posted in Oct 2014, 1 year 6 months after primary completion.
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This study is terminated, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Boceprevir