Herpes Simplex
Conditions
Keywords
herpes simplex, cold sores, fever blisters, children, Famvir, famciclovir
Brief summary
This study will evaluate the safety and blood levels of a new pediatric formulation of Famvir in children 1-12 years of age. In Part A, patients will receive a single dose of famciclovir (12.5 mg/kg) to assess pharmacokinetics (PK) and safety. In Part B, patients will receive multiple doses of famciclovir alone or with concomitant oral anti-herpes therapy to assess safety and tolerability. Part B will start only after PK data from Part A had been analyzed.
Interventions
DRUGFamciclovir
Famciclovir sprinkle capsules, 25 mg and 100 mg, using OraSweet® syrup vehicle
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
* History or laboratory evidence of herpes simplex infection * Clinical evidence or suspicion of herpes simplex infection
Exclusion criteria
* Patients unable to swallow * Concomitant use of probenecid * Positive pregnancy test Additional protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Tolerability of Famciclovir Pediatric Oral Formulation in Part B of the Study. | Administered 2 times daily over 7 days | A patient with multiple AEs within the primary system organ class is counted only once in total row. |
| Area Under the Penciclovir Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-∞) | Plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose | PK parameter; penciclovir is the active metabolite of famciclovir. |
| Apparent Oral Clearance of Penciclovir (CL/F) | Plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose | PK parameter; penciclovir is the active metabolite of famciclovir. |
| Apparent Terminal Elimination Half-life of Penciclovir (T1/2) | Plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose | PK parameter; penciclovir is the active metabolite of famciclovir |
| Time of Maximum Observed Plasma Concentration of Penciclovir (Tmax) | Plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose | PK parameter; penciclovir is the active metabolite of famciclovir. |
| Safety and Tolerability of a Single-dose of Famciclovir in Part A of the Study. | 8 hours and 24 hours after study drug administration (Part A) | A patient with multiple adverse events (AEs) within the primary system organ class is counted only once in total row. |
| Maximum Observed Plasma Concentration of Penciclovir (Cmax) | plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose | PK parameter; penciclovir is the active metabolite of famciclovir. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Acceptability of Pediatric Oral Formulation by Patients in Part B of the Study. | Day 1 at clinic: after swallowing first dose | Overall acceptability of the study medication was determined by caretaker response. |
| Overall Acceptability of Pediatric Oral Formulation by Patients in Part B of the Study | Day 8 at home: after swallowing last dose | Overall acceptability of study medication was determined by caretaker response. |
| Overall Acceptability of Pediatric Oral Formulation by Patients in Part A of the Study. | Day 1, after swallowing the dose. | Overall acceptability of the study medication was determined by caretaker response. |
Countries
Panama, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Part A (Single-dose of Famciclovir) Each patient in Part A received a single dose of famciclovir (12.5 mg/kg). | 27 |
| Part B (Multiple-dose of Famciclovir) Each patient in Part B received famciclovir twice a day (b.i.d.) approximately 12 hours apart for 7 days for a total of 14 doses. An 8-step dosing scheme (ranged from 150 mg b.i.d. to 500 mg b.i.d.) was used to determine the weight-based adjusted daily dose. | 47 |
| Total | 74 |
Baseline characteristics
| Characteristic | Total | Part B (Multiple-dose of Famciclovir) | Part A (Single-dose of Famciclovir) |
|---|---|---|---|
| Age, Customized 13 to <=18 years | 2 participants | 0 participants | 2 participants |
| Age, Customized 1 to <2 years | 17 participants | 13 participants | 4 participants |
| Age, Customized 2 to <6 years | 29 participants | 16 participants | 13 participants |
| Age, Customized 6 to <=12 years | 26 participants | 18 participants | 8 participants |
| Sex: Female, Male Female | 41 Participants | 24 Participants | 17 Participants |
| Sex: Female, Male Male | 33 Participants | 23 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 5 / 27 | 23 / 47 |
| serious Total, serious adverse events | 0 / 27 | 0 / 47 |
Outcome results
Primary
Apparent Oral Clearance of Penciclovir (CL/F)
PK parameter; penciclovir is the active metabolite of famciclovir.
Time frame: Plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose
Population: Includes 26 of 27 patients enrolled in Part A of the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1 to < 2 Years | Apparent Oral Clearance of Penciclovir (CL/F) | 20.8 L/h | Full Range 8.5 |
| 2 to <6 Years | Apparent Oral Clearance of Penciclovir (CL/F) | 25.1 L/h | Full Range 4.3 |
| 6 to <13 Years | Apparent Oral Clearance of Penciclovir (CL/F) | 43.7 L/h | Full Range 9.6 |
| 13 to <=18 Years | Apparent Oral Clearance of Penciclovir (CL/F) | 68.8 L/h | Full Range 0 |
Primary
Apparent Terminal Elimination Half-life of Penciclovir (T1/2)
PK parameter; penciclovir is the active metabolite of famciclovir
Time frame: Plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose
Population: Includes 26 of 27 patients enrolled in Part A of the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1 to < 2 Years | Apparent Terminal Elimination Half-life of Penciclovir (T1/2) | 1.09 hours | Full Range 0.08 |
| 2 to <6 Years | Apparent Terminal Elimination Half-life of Penciclovir (T1/2) | 1.36 hours | Full Range 0.2 |
| 6 to <13 Years | Apparent Terminal Elimination Half-life of Penciclovir (T1/2) | 1.60 hours | Full Range 0.25 |
| 13 to <=18 Years | Apparent Terminal Elimination Half-life of Penciclovir (T1/2) | 1.86 hours | — |
Primary
Area Under the Penciclovir Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-∞)
PK parameter; penciclovir is the active metabolite of famciclovir.
Time frame: Plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose
Population: Includes 26 of 27 patients enrolled in Part A of the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1 to < 2 Years | Area Under the Penciclovir Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-∞) | 6.17 (μg/mL)h | Full Range 2.42 |
| 2 to <6 Years | Area Under the Penciclovir Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-∞) | 6.85 (μg/mL)h | Full Range 1.55 |
| 6 to <13 Years | Area Under the Penciclovir Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-∞) | 8.15 (μg/mL)h | Full Range 1.01 |
| 13 to <=18 Years | Area Under the Penciclovir Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-∞) | 5.93 (μg/mL)h | Full Range 0 |
Primary
Maximum Observed Plasma Concentration of Penciclovir (Cmax)
PK parameter; penciclovir is the active metabolite of famciclovir.
Time frame: plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose
Population: Includes all 27 patients enrolled in Part A of the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1 to < 2 Years | Maximum Observed Plasma Concentration of Penciclovir (Cmax) | 2.84 μg/mL | Full Range 1.25 |
| 2 to <6 Years | Maximum Observed Plasma Concentration of Penciclovir (Cmax) | 2.44 μg/mL | Full Range 0.94 |
| 6 to <13 Years | Maximum Observed Plasma Concentration of Penciclovir (Cmax) | 2.82 μg/mL | Full Range 0.65 |
| 13 to <=18 Years | Maximum Observed Plasma Concentration of Penciclovir (Cmax) | 1.89 μg/mL | — |
Primary
Safety and Tolerability of a Single-dose of Famciclovir in Part A of the Study.
A patient with multiple adverse events (AEs) within the primary system organ class is counted only once in total row.
Time frame: 8 hours and 24 hours after study drug administration (Part A)
Population: Includes all 27 patients enrolled in Part A of the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1 to < 2 Years | Safety and Tolerability of a Single-dose of Famciclovir in Part A of the Study. | Patients with AEs | 0 participants |
| 1 to < 2 Years | Safety and Tolerability of a Single-dose of Famciclovir in Part A of the Study. | Gastrointestinal disorders | 0 participants |
| 1 to < 2 Years | Safety and Tolerability of a Single-dose of Famciclovir in Part A of the Study. | Nervous system disorders | 0 participants |
| 1 to < 2 Years | Safety and Tolerability of a Single-dose of Famciclovir in Part A of the Study. | General disorders and administration site | 0 participants |
| 1 to < 2 Years | Safety and Tolerability of a Single-dose of Famciclovir in Part A of the Study. | Infections and infestations | 0 participants |
| 1 to < 2 Years | Safety and Tolerability of a Single-dose of Famciclovir in Part A of the Study. | Skin and subcutaneous tissue disorders | 0 participants |
| 2 to <6 Years | Safety and Tolerability of a Single-dose of Famciclovir in Part A of the Study. | Skin and subcutaneous tissue disorders | 1 participants |
| 2 to <6 Years | Safety and Tolerability of a Single-dose of Famciclovir in Part A of the Study. | General disorders and administration site | 0 participants |
| 2 to <6 Years | Safety and Tolerability of a Single-dose of Famciclovir in Part A of the Study. | Patients with AEs | 2 participants |
| 2 to <6 Years | Safety and Tolerability of a Single-dose of Famciclovir in Part A of the Study. | Nervous system disorders | 0 participants |
| 2 to <6 Years | Safety and Tolerability of a Single-dose of Famciclovir in Part A of the Study. | Gastrointestinal disorders | 1 participants |
| 2 to <6 Years | Safety and Tolerability of a Single-dose of Famciclovir in Part A of the Study. | Infections and infestations | 1 participants |
| 6 to <13 Years | Safety and Tolerability of a Single-dose of Famciclovir in Part A of the Study. | Gastrointestinal disorders | 0 participants |
| 6 to <13 Years | Safety and Tolerability of a Single-dose of Famciclovir in Part A of the Study. | Nervous system disorders | 1 participants |
| 6 to <13 Years | Safety and Tolerability of a Single-dose of Famciclovir in Part A of the Study. | General disorders and administration site | 0 participants |
| 6 to <13 Years | Safety and Tolerability of a Single-dose of Famciclovir in Part A of the Study. | Skin and subcutaneous tissue disorders | 0 participants |
| 6 to <13 Years | Safety and Tolerability of a Single-dose of Famciclovir in Part A of the Study. | Infections and infestations | 0 participants |
| 6 to <13 Years | Safety and Tolerability of a Single-dose of Famciclovir in Part A of the Study. | Patients with AEs | 1 participants |
| 13 to <=18 Years | Safety and Tolerability of a Single-dose of Famciclovir in Part A of the Study. | Infections and infestations | 0 participants |
| 13 to <=18 Years | Safety and Tolerability of a Single-dose of Famciclovir in Part A of the Study. | Skin and subcutaneous tissue disorders | 0 participants |
| 13 to <=18 Years | Safety and Tolerability of a Single-dose of Famciclovir in Part A of the Study. | Gastrointestinal disorders | 1 participants |
| 13 to <=18 Years | Safety and Tolerability of a Single-dose of Famciclovir in Part A of the Study. | General disorders and administration site | 1 participants |
| 13 to <=18 Years | Safety and Tolerability of a Single-dose of Famciclovir in Part A of the Study. | Patients with AEs | 2 participants |
| 13 to <=18 Years | Safety and Tolerability of a Single-dose of Famciclovir in Part A of the Study. | Nervous system disorders | 1 participants |
Primary
Safety and Tolerability of Famciclovir Pediatric Oral Formulation in Part B of the Study.
A patient with multiple AEs within the primary system organ class is counted only once in total row.
Time frame: Administered 2 times daily over 7 days
Population: Includes 47 patients enrolled in Part B of the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1 to < 2 Years | Safety and Tolerability of Famciclovir Pediatric Oral Formulation in Part B of the Study. | Vascular disorders | 0 participants |
| 1 to < 2 Years | Safety and Tolerability of Famciclovir Pediatric Oral Formulation in Part B of the Study. | Respiratory, thoracic and mediastinal disorders | 1 participants |
| 1 to < 2 Years | Safety and Tolerability of Famciclovir Pediatric Oral Formulation in Part B of the Study. | Investigations | 1 participants |
| 1 to < 2 Years | Safety and Tolerability of Famciclovir Pediatric Oral Formulation in Part B of the Study. | Skin and subcutaneous tissue disorders | 1 participants |
| 1 to < 2 Years | Safety and Tolerability of Famciclovir Pediatric Oral Formulation in Part B of the Study. | Infections and infestations | 3 participants |
| 1 to < 2 Years | Safety and Tolerability of Famciclovir Pediatric Oral Formulation in Part B of the Study. | Patients with AEs | 6 participants |
| 1 to < 2 Years | Safety and Tolerability of Famciclovir Pediatric Oral Formulation in Part B of the Study. | Nervous system disorders | 0 participants |
| 1 to < 2 Years | Safety and Tolerability of Famciclovir Pediatric Oral Formulation in Part B of the Study. | Gastrointestinal disorders | 4 participants |
| 1 to < 2 Years | Safety and Tolerability of Famciclovir Pediatric Oral Formulation in Part B of the Study. | Injury, poisoning and procedural complications | 0 participants |
| 1 to < 2 Years | Safety and Tolerability of Famciclovir Pediatric Oral Formulation in Part B of the Study. | General disorders and administration site | 3 participants |
| 1 to < 2 Years | Safety and Tolerability of Famciclovir Pediatric Oral Formulation in Part B of the Study. | Metabolism and nutrition disorders | 1 participants |
| 2 to <6 Years | Safety and Tolerability of Famciclovir Pediatric Oral Formulation in Part B of the Study. | Infections and infestations | 0 participants |
| 2 to <6 Years | Safety and Tolerability of Famciclovir Pediatric Oral Formulation in Part B of the Study. | Patients with AEs | 8 participants |
| 2 to <6 Years | Safety and Tolerability of Famciclovir Pediatric Oral Formulation in Part B of the Study. | Gastrointestinal disorders | 3 participants |
| 2 to <6 Years | Safety and Tolerability of Famciclovir Pediatric Oral Formulation in Part B of the Study. | Nervous system disorders | 2 participants |
| 2 to <6 Years | Safety and Tolerability of Famciclovir Pediatric Oral Formulation in Part B of the Study. | General disorders and administration site | 1 participants |
| 2 to <6 Years | Safety and Tolerability of Famciclovir Pediatric Oral Formulation in Part B of the Study. | Respiratory, thoracic and mediastinal disorders | 1 participants |
| 2 to <6 Years | Safety and Tolerability of Famciclovir Pediatric Oral Formulation in Part B of the Study. | Skin and subcutaneous tissue disorders | 2 participants |
| 2 to <6 Years | Safety and Tolerability of Famciclovir Pediatric Oral Formulation in Part B of the Study. | Vascular disorders | 0 participants |
| 2 to <6 Years | Safety and Tolerability of Famciclovir Pediatric Oral Formulation in Part B of the Study. | Injury, poisoning and procedural complications | 1 participants |
| 2 to <6 Years | Safety and Tolerability of Famciclovir Pediatric Oral Formulation in Part B of the Study. | Investigations | 0 participants |
| 2 to <6 Years | Safety and Tolerability of Famciclovir Pediatric Oral Formulation in Part B of the Study. | Metabolism and nutrition disorders | 0 participants |
| 6 to <13 Years | Safety and Tolerability of Famciclovir Pediatric Oral Formulation in Part B of the Study. | Investigations | 0 participants |
| 6 to <13 Years | Safety and Tolerability of Famciclovir Pediatric Oral Formulation in Part B of the Study. | Vascular disorders | 2 participants |
| 6 to <13 Years | Safety and Tolerability of Famciclovir Pediatric Oral Formulation in Part B of the Study. | Nervous system disorders | 5 participants |
| 6 to <13 Years | Safety and Tolerability of Famciclovir Pediatric Oral Formulation in Part B of the Study. | Patients with AEs | 12 participants |
| 6 to <13 Years | Safety and Tolerability of Famciclovir Pediatric Oral Formulation in Part B of the Study. | Injury, poisoning and procedural complications | 1 participants |
| 6 to <13 Years | Safety and Tolerability of Famciclovir Pediatric Oral Formulation in Part B of the Study. | Gastrointestinal disorders | 6 participants |
| 6 to <13 Years | Safety and Tolerability of Famciclovir Pediatric Oral Formulation in Part B of the Study. | Infections and infestations | 0 participants |
| 6 to <13 Years | Safety and Tolerability of Famciclovir Pediatric Oral Formulation in Part B of the Study. | Respiratory, thoracic and mediastinal disorders | 2 participants |
| 6 to <13 Years | Safety and Tolerability of Famciclovir Pediatric Oral Formulation in Part B of the Study. | Metabolism and nutrition disorders | 0 participants |
| 6 to <13 Years | Safety and Tolerability of Famciclovir Pediatric Oral Formulation in Part B of the Study. | Skin and subcutaneous tissue disorders | 0 participants |
| 6 to <13 Years | Safety and Tolerability of Famciclovir Pediatric Oral Formulation in Part B of the Study. | General disorders and administration site | 1 participants |
Primary
Time of Maximum Observed Plasma Concentration of Penciclovir (Tmax)
PK parameter; penciclovir is the active metabolite of famciclovir.
Time frame: Plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose
Population: Includes all 27 patients enrolled in Part A of the study.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 1 to < 2 Years | Time of Maximum Observed Plasma Concentration of Penciclovir (Tmax) | 1.21 hours |
| 2 to <6 Years | Time of Maximum Observed Plasma Concentration of Penciclovir (Tmax) | 1.07 hours |
| 6 to <13 Years | Time of Maximum Observed Plasma Concentration of Penciclovir (Tmax) | 1.00 hours |
| 13 to <=18 Years | Time of Maximum Observed Plasma Concentration of Penciclovir (Tmax) | 1.47 hours |
Secondary
Overall Acceptability of Pediatric Oral Formulation by Patients in Part A of the Study.
Overall acceptability of the study medication was determined by caretaker response.
Time frame: Day 1, after swallowing the dose.
Population: Includes all 27 patients enrolled in Part A of the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1 to < 2 Years | Overall Acceptability of Pediatric Oral Formulation by Patients in Part A of the Study. | Badly | 1 participants |
| 1 to < 2 Years | Overall Acceptability of Pediatric Oral Formulation by Patients in Part A of the Study. | Well | 2 participants |
| 1 to < 2 Years | Overall Acceptability of Pediatric Oral Formulation by Patients in Part A of the Study. | Neither bad nor good | 1 participants |
| 2 to <6 Years | Overall Acceptability of Pediatric Oral Formulation by Patients in Part A of the Study. | Badly | 4 participants |
| 2 to <6 Years | Overall Acceptability of Pediatric Oral Formulation by Patients in Part A of the Study. | Well | 8 participants |
| 2 to <6 Years | Overall Acceptability of Pediatric Oral Formulation by Patients in Part A of the Study. | Neither bad nor good | 1 participants |
| 6 to <13 Years | Overall Acceptability of Pediatric Oral Formulation by Patients in Part A of the Study. | Neither bad nor good | 4 participants |
| 6 to <13 Years | Overall Acceptability of Pediatric Oral Formulation by Patients in Part A of the Study. | Badly | 0 participants |
| 6 to <13 Years | Overall Acceptability of Pediatric Oral Formulation by Patients in Part A of the Study. | Well | 4 participants |
| 13 to <=18 Years | Overall Acceptability of Pediatric Oral Formulation by Patients in Part A of the Study. | Badly | 2 participants |
| 13 to <=18 Years | Overall Acceptability of Pediatric Oral Formulation by Patients in Part A of the Study. | Well | 0 participants |
| 13 to <=18 Years | Overall Acceptability of Pediatric Oral Formulation by Patients in Part A of the Study. | Neither bad nor good | 0 participants |
Secondary
Overall Acceptability of Pediatric Oral Formulation by Patients in Part B of the Study
Overall acceptability of study medication was determined by caretaker response.
Time frame: Day 8 at home: after swallowing last dose
Population: Includes all 47 patients enrolled in Part B of the study. Response was not available for 1 patient in the 2 to \<6 years and 6 to \<=12 years groups.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1 to < 2 Years | Overall Acceptability of Pediatric Oral Formulation by Patients in Part B of the Study | Neither bad nor good | 3 participants |
| 1 to < 2 Years | Overall Acceptability of Pediatric Oral Formulation by Patients in Part B of the Study | Badly | 7 participants |
| 1 to < 2 Years | Overall Acceptability of Pediatric Oral Formulation by Patients in Part B of the Study | Well | 3 participants |
| 2 to <6 Years | Overall Acceptability of Pediatric Oral Formulation by Patients in Part B of the Study | Neither bad nor good | 3 participants |
| 2 to <6 Years | Overall Acceptability of Pediatric Oral Formulation by Patients in Part B of the Study | Badly | 5 participants |
| 2 to <6 Years | Overall Acceptability of Pediatric Oral Formulation by Patients in Part B of the Study | Well | 7 participants |
| 6 to <13 Years | Overall Acceptability of Pediatric Oral Formulation by Patients in Part B of the Study | Badly | 3 participants |
| 6 to <13 Years | Overall Acceptability of Pediatric Oral Formulation by Patients in Part B of the Study | Well | 11 participants |
| 6 to <13 Years | Overall Acceptability of Pediatric Oral Formulation by Patients in Part B of the Study | Neither bad nor good | 3 participants |
Secondary
Overall Acceptability of Pediatric Oral Formulation by Patients in Part B of the Study.
Overall acceptability of the study medication was determined by caretaker response.
Time frame: Day 1 at clinic: after swallowing first dose
Population: Includes all 47 patients enrolled in Part B of the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1 to < 2 Years | Overall Acceptability of Pediatric Oral Formulation by Patients in Part B of the Study. | Neither bad nor good | 2 participants |
| 1 to < 2 Years | Overall Acceptability of Pediatric Oral Formulation by Patients in Part B of the Study. | Badly | 9 participants |
| 1 to < 2 Years | Overall Acceptability of Pediatric Oral Formulation by Patients in Part B of the Study. | Well | 2 participants |
| 2 to <6 Years | Overall Acceptability of Pediatric Oral Formulation by Patients in Part B of the Study. | Neither bad nor good | 1 participants |
| 2 to <6 Years | Overall Acceptability of Pediatric Oral Formulation by Patients in Part B of the Study. | Badly | 6 participants |
| 2 to <6 Years | Overall Acceptability of Pediatric Oral Formulation by Patients in Part B of the Study. | Well | 9 participants |
| 6 to <13 Years | Overall Acceptability of Pediatric Oral Formulation by Patients in Part B of the Study. | Badly | 7 participants |
| 6 to <13 Years | Overall Acceptability of Pediatric Oral Formulation by Patients in Part B of the Study. | Well | 9 participants |
| 6 to <13 Years | Overall Acceptability of Pediatric Oral Formulation by Patients in Part B of the Study. | Neither bad nor good | 2 participants |