Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Part A (Single-dose of Famciclovir)	Includes 27 patients enrolled in Part A. Two adolescent patients (13 to 18 years) were enrolled in Part A of this study under an amendment to the protocol to include adolescent aged patients. The amendment was rescinded in compliance with an FDA Pediatric Written Request and no further adolescent aged patients were enrolled.
Part B (Multiple-dose of Famciclovir)	Includes 47 patients enrolled in Part B. Part B started only after pharmacokinetic (PK) data from Part A had been analyzed. One patient that participated in Part A of the study also participated in Part B.

Participant Flow:   Overall Study

	Part A (Single-dose of Famciclovir)	Part B (Multiple-dose of Famciclovir)
STARTED	27	47
COMPLETED	27	46
NOT COMPLETED	0	1

Reporting Groups

	Description
Part A (Single-dose of Famciclovir)	Each patient in Part A received a single dose of famciclovir (12.5 mg/kg).
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.

Baseline Measures

	Part A (Single-dose of Famciclovir)	Part B (Multiple-dose of Famciclovir)	Total
Number of Participants   [units: participants]	27	47	74
Age, Customized   [units: participants]
1 to <2 years	4	13	17
2 to <6 years	13	16	29
6 to 12 years	8	18	26
13 to 18 years	2	0	2
Gender   [units: participants]
Female	17	24	41
Male	10	23	33

1.  Primary:

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) ]

2.  Primary:

Maximum Observed Plasma Concentration of Penciclovir (Cmax)   [ plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose ]

3.  Primary:

Time of Maximum Observed Plasma Concentration of Penciclovir (Tmax)   [ Plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose ]

4.  Primary:

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 ]

5.  Primary:

Apparent Oral Clearance of Penciclovir (CL/F)   [ Plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose ]

6.  Primary:

Apparent Terminal Elimination Half-life of Penciclovir (T1/2)   [ Plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose ]

7.  Primary:

Safety and Tolerability of Famciclovir Pediatric Oral Formulation in Part B of the Study.   [ Administered 2 times daily over 7 days ]

8.  Secondary:

Overall Acceptability of Pediatric Oral Formulation by Patients in Part A of the Study.   [ Immediately after dose administration and 2-5 minutes later ]

9.  Secondary:

Overall Acceptability of Pediatric Oral Formulation by Patients in Part B of the Study.   [ Day 1 at clinic: after swallowing first dose ]

10.  Secondary:

Overall Acceptability of Pediatric Oral Formulation by Patients in Part B of the Study   [ Day 8 at home: after swallowing last dose ]