Safety and Pharmacokinetics of Famciclovir Single 1500 mg Dose in Adolescents With Recurrent Herpes Labialis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00878072
First received: April 7, 2009
Last updated: May 1, 2012
Last verified: May 2012
  Purpose

This study will assess the safety, tolerability of a single 1500 mg dose of famciclovir in 50 adolescents with recurrent herpes labialis. Eight of the 50 adolescents will also participate in the pharmacokinetics (PK) assessment of famciclovir single 1500 mg dose


Condition Intervention Phase
Herpes Labialis
Drug: Famciclovir
Phase 2
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter, Open-label, Single-arm Study to Evaluate the Safety and Pharmacokinetics of Famciclovir Single 1500 mg Dose in Adolescents With Recurrent Herpes Labialis

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Safety: Frequency of adverse events and laboratory abnormalities [ Time Frame: 48 hours, 4 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetics: Measure: AUC0-tlast (area under the penciclovir concentration-time curve from time zero to the last measurable timepoint) [ Time Frame: Pre-dose, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, and 10.0 hours post-dose ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics: Measure: AUC0-∞ (area under the penciclovir concentration-time curve from time zero to infinity) [ Time Frame: Pre-dose, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, and 10.0 hours post-dose ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics: Measure: Cmax (maximum observed plasma concentration of penciclovir post-dose) [ Time Frame: Pre-dose, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, and 10.0 hours post-dose ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics: Measure: CL/F (apparent oral clearance of penciclovir) [ Time Frame: Pre-dose, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, and 10.0 hours post-dose ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics: Measure: Tmax (time of maximum observed plasma concentration of penciclovir) [ Time Frame: Pre-dose, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, and 10.0 hours post-dose ] [ Designated as safety issue: Yes ]

Enrollment: 53
Study Start Date: March 2009
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Famciclovir Drug: Famciclovir
Famciclovir 1500 mg (3 x 500 mg tablets) oral as a single dose.

Detailed Description:

Uncontrolled study

  Eligibility

Ages Eligible for Study:   12 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Outpatient males or females 12 to <18 years of age
  • General good health with a documented history typical for recurrent herpes labialis
  • Prodromal symptoms or active lesions suggestive of a recurrent episode of herpes labialis (i.e. having had cold sores in the past) , with onset not exceeding 24 hours until the time of study drug administration

    • Adolescents participating in PK part of the study may be enrolled without an active herpes labialis recurrence or with onset of signs/symptoms of a recurrent herpes labialis episode longer than 24 hours before study drug administration, All adolescents participating in the pharmacokinetics assessments must fast for at least 8 hours prior to Visit 1 and be willing to fast for an additional 2 hours after study drug administration

Exclusion Criteria:

  • Use of other investigational drugs within 30 days of enrollment
  • History of hypersensitivity to famciclovir or penciclovir
  • Inability to swallow tablets
  • Body weight less than 40 kg
  • History of malabsorption, unless a condition like celiac disease is stable and well controlled, previous gastrointestinal surgery or radiation therapy that could affect drug absorption or metabolism, or any condition that could interfere with drug absorption, distribution, metabolism, or excretion
  • Known renal insufficiency (calculated creatinine clearance <60 mL/min)
  • Known severe hepatic impairment (Child-Pugh Class C)
  • Significant skin disease such as atopic dermatitis or eczema that would interfere with assessment of oral/labial lesions
  • Known to be immunocompromised or are receiving systemic or using topical immunosuppressive agents (including corticosteroids, tacrolimus and picrolimus) within 30 days of enrollment
  • Concomitant use of probenecid
  • Pregnant or nursing (lactating) females
  • Females of child-bearing potential, UNLESS they are using two birth control methods. The two methods can be a double barrier method or a barrier method plus a hormonal method.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00878072

Locations
United States, California
Women's Health Care at Frost Street
San Diego, California, United States
United States, Illinois
Children's Memorial Hospital
Chicago, Illinois, United States, 60614
United States, Indiana
Medisphere Medical Research Center, LLC
Evansville, Indiana, United States, 47714
United States, Missouri
Clayton Medical Research
St. Louis, Missouri, United States, 63117
United States, New York
Rochester Clinical Research, Inc.
Rochester, New York, United States
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106
United States, Oregon
Westover Heights Clinic
Portland, Oregon, United States, 97210
United States, Pennsylvania
Primary Physicians Research, Inc
Pittsburgh, Pennsylvania, United States
United States, Texas
Texas Children's Hospital
Houston, Texas, United States, 77030
R/D Clinical Research, Inc
Lake Jackson, Texas, United States, 77566
R/D Clinical Research
Lake Jackson, Texas, United States, 77566
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Additional Information:
No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00878072     History of Changes
Other Study ID Numbers: CFAM810B2305
Study First Received: April 7, 2009
Last Updated: May 1, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Herpes labialis
cold sores
herpes simplex type 1

Additional relevant MeSH terms:
Herpes Labialis
Herpes Simplex
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Lip Diseases
Mouth Diseases
Stomatognathic Diseases
Skin Diseases, Infectious
Skin Diseases
Famciclovir
2-Aminopurine
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 22, 2014