Pharmacokinetics, Acceptability and Safety of Famciclovir in Infants (1 Month to Less Than 12 Months) With Herpes Simplex Infection

Herpes Simplex Clinical Trial

Official title:

A Multicenter, Open-label, Single-arm Study to Evaluate the Single-dose Pharmacokinetics, Acceptability and Safety of Famciclovir Oral Pediatric Formulation in Infants 1 Month to Less Than 1 Year of Age With Herpes Simplex Virus Infections

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00448227
• Other study ID #: CFAM810B2301
• Status: Completed
• Phase: Phase 2
• First received: March 15, 2007
• Last updated: February 9, 2011
• Start date: October 2007

Study information

• Verified date: February 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationGermany: Federal Institute for Drugs and Medical DevicesGuatemala: Ministry of Health Commission for Clinical Trials Evaluation
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the acceptability and safety of famciclovir in infants with herpes simplex infection

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Month to 1 Year

Eligibility

Inclusion Criteria:

• Male and female patients from 1 month up to 1 year of age with herpes simplex infection

Exclusion Criteria:

• Patients with gestational age less than 32 weeks. Patients unable to swallow. Patients with history of malabsorption or previous gastrointestinal surgery.

Other protocol-defined inclusion/exclusion criteria may apply.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Herpes Simplex

Intervention

Drug:
• famciclovir
Administered orally as a single individualized dose between 25-200 mg based on body weight.

Locations

Country	Name	City	State
United States	Pediatric Infectious Disease Of University of Alabama	Birmingham	Alabama
United States	Children's Memorial Hospital Chicago	Chicago	Illinois
United States	University Hospital Cased Medical Center Rainbow Babies and Children's Hospital	Cleveland	Ohio
United States	UT Southwestern Medical Center	Dallas	Texas
United States	Children's Hospital of Michigan	Detroit	Michigan
United States	Archana Chatterjee	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics of Single Dose - Tmax	Measured by Tmax - The time after administration of a drug when the maximum plasma concentration is reached.	Plasma samples were collected at 0.5, 1, 4 and 6 hours after dosing.	No
Primary	Pharmacokinetics of Single Dose - Cmax	Measured by Cmax - The maximum plasma concentration of study medication	Plasma samples were collected at 0.5, 1, 4 and 6 hours after dosing.	No
Primary	Pharmacokinetics of Single Dose - AUC(0-tlast)	Measured by AUC(0-tlast) - Area under the plasma concentration time curve from time zero to the last quantifiable concentration-timepoint.	Plasma samples were collected at 0.5, 1, 4 and 6 hours after dosing.	No
Primary	Pharmacokinetics of Single Dose - AUC(0-6h)	Measured by AUC(0-6h) - Area under the plasma concentration time curve from time zero up to 6 hours post dose (i.e. the time of the last sample).	Plasma samples were collected at 0.5, 1, 4 and 6 hours after dosing.	No
Secondary	Safety Assessed by AEs, SAEs	AEs and SAEs were collected during patient's stay in the clinic for PK sampling up to Hour 8, then at day 2 visit, 8 days(safety follow-up call) and 38 days (safety follow-up call) post dose.	38 days	No
Secondary	Safety Assessed by Labs	Samples for safety labs were obtained at baseline and Day 2 visit and samples were analyzed by local accredited laboratory.	2 days	No
Secondary	Tolerability of of the Famciclovir Pediatric Formulation as Assessed by Study Personnel.	Tolerability was assessed by the study personnel 30 minutes after dosing using the following scale: Significant emesis occurred,; Infant spit out most of the dose ingesting less than half of what was administered,; Infant spit out some of the dose, but ingested at least 50% of what was administered,; Infant was able to ingest and retain the dose administered	30 minutes after dosing	No
Secondary	Acceptability of the Famciclovir Pediatric Formulation as Assessed by the Patient's Caregiver	Assessed by the caregiver using a 5-point scale immediately after dosing: Very badly accepted/unacceptable: infant showed great displeasure, compromising use of formulation; Badly but accepted: infant showed displeasure with dosing but could be coaxed to take complete dose; Neither good nor bad: infant showed no apparent displeasure and with little effort was coaxed to take complete dose; Well accepted: infant appeared to enjoy the formulation and with little coaxing ingested most of dose; Very well accepted: infant appeared eager and ingested most of dose without special coaxing	Immediately after dosing	No
Secondary	Acceptability of the Famciclovir Pediatric Formulation as Assessed by Study Personnel	Assessed by the study personnel using a 5-point scale after dosing: Very badly accepted/unacceptable: infant showed great displeasure, compromising use of formulation; Badly but accepted: infant showed displeasure with dosing but could be coaxed to take complete dose; Neither good nor bad: infant showed no apparent displeasure and with little effort was coaxed to take complete dose; Well accepted: infant appeared to enjoy the formulation and with little coaxing ingested most of dose; Very well accepted: infant appeared eager and ingested most of dose without special coaxing	Immediately after dosing	No

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