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NCT Number: NCT00098059

Famciclovir Pediatric Formulation in Children 1 to 12 Years of Age With Herpes Simplex Infection

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.

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Key information

Conditions

Herpes Simplex DNA Virus Infections Herpes Labialis Herpesviridae Infections Infections Lip Diseases Mouth Diseases Skin Diseases Skin Diseases, Infectious Skin Diseases, Viral Skin and Connective Tissue Diseases Stomatognathic Diseases Virus Diseases

Age range

1 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Panama Minister of Health, David, Chiriquí Province, Panama

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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/exclusion criteria may apply. For detailed information on eligibility, please contact the study center nearest to you or call the following numbers: 1-862-778-3544 or 1-434-951-3228

Treatment and study plan

Famciclovir

Drug

Famciclovir sprinkle capsules, 25 mg and 100 mg, using OraSweet® syrup vehicle

Primary outcomes

  1. Safety and Tolerability of a Single-dose of Famciclovir in Part A of the Study.

    Time frame: 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.

  2. Maximum Observed Plasma Concentration of Penciclovir (Cmax)

    Time frame: plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose

    PK parameter; penciclovir is the active metabolite of famciclovir.

  3. Time of Maximum Observed Plasma Concentration of Penciclovir (Tmax)

    Time frame: Plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose

    PK parameter; penciclovir is the active metabolite of famciclovir.

  4. Area Under the Penciclovir Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-∞)

    Time frame: Plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose

    PK parameter; penciclovir is the active metabolite of famciclovir.

  5. Apparent Oral Clearance of Penciclovir (CL/F)

    Time frame: Plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose

    PK parameter; penciclovir is the active metabolite of famciclovir.

  6. Apparent Terminal Elimination Half-life of Penciclovir (T1/2)

    Time frame: Plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose

    PK parameter; penciclovir is the active metabolite of famciclovir

  7. Safety and Tolerability of Famciclovir Pediatric Oral Formulation in Part B of the Study.

    Time frame: 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.

Secondary outcomes

  1. Overall Acceptability of Pediatric Oral Formulation by Patients in Part A of the Study.

    Time frame: Day 1, after swallowing the dose.

    Overall acceptability of the study medication was determined by caretaker response.

  2. Overall Acceptability of Pediatric Oral Formulation by Patients in Part B of the Study.

    Time frame: Day 1 at clinic: after swallowing first dose

    Overall acceptability of the study medication was determined by caretaker response.

  3. Overall Acceptability of Pediatric Oral Formulation by Patients in Part B of the Study

    Time frame: Day 8 at home: after swallowing last dose

    Overall acceptability of study medication was determined by caretaker response.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

A Multicenter, Open-label, Single-arm, Two-step Study to Evaluate the Safety and Single-dose Pharmacokinetics of Famciclovir and Multiple-dose Safety After Administration of Famciclovir Oral Pediatric Formulation to Children 1 to 12 Years of Age With Herpes Simplex Infection

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Dec 3, 2004
Registry last updated
Apr 25, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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