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

NCT00878072 | Completed Phase 2 Results

• 1 other identifier: CFAM810B2305
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 12

Brief Summary

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

Conditions

Herpes Labialis

Keywords

Herpes labialis; cold sores; herpes simplex type 1

Outcome Measures

Primary Outcomes (2)

• Number of Participants Reported Adverse Events (AEs), Serious Adverse Events (SAEs)

  AEs are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.

  From Start of the Study up to Day 36

• Number of Participants With Clinically Significant Laboratory Abnormalities

  Participants with laboratory values outside the defined normal range were graded as clinically significant laboratory abnormalities. Laboratory values were assessed according to the National Cancer Institute- Common terminology criteria for Adverse Events (NCI-CTCAE). Hematology, Urinalysis and clinical chemistry were reported .

  From Start of the Study up to Day 36

Secondary Outcomes (6)

• Time of Maximum Observed Plasma Concentration (Tmax) of Penciclovir (Active Metabolite From Famciclovir) and 6-deoxypenciclovir (First Intermediate Metabolite From Famciclovir)

  Pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6 and 10 hours Post-dose

• Maximum Plasma Concentration (Cmax) of Penciclovir (Active Metabolite From Famciclovir) and 6-deoxypenciclovir (First Intermediate Metabolite From Famciclovir)

  Pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6 and 10 hours Post-dose

• Area Under the Plasma Concentration of Penciclovir (Active Metabolite From Famciclovir) and 6-deoxypenciclovir (First Intermediate Metabolite From Famciclovir)

  Pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6 and 10 hours Post-dose

• Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity (AUC 0-infinity) of Penciclovir (Active Metabolite From Famciclovir) and 6-deoxypenciclovir (First Intermediate Metabolite From Famciclovir)

  Pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6 and 10 hours Post-dose

• Apparent Terminal Elimination Half-Life (T½) of Penciclovir (Active Metabolite From Famciclovir) and 6-deoxypenciclovir (First Intermediate Metabolite From Famciclovir)

  Pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6 and 10 hours Post-dose

Study Arms (1)

Famciclovir

EXPERIMENTAL

Drug: Famciclovir

Interventions

Famciclovir DRUG

Famciclovir 1500 mg (3 x 500 mg tablets) oral as a single dose.

Famciclovir

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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 Pharmacokinetics (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

You may not qualify if:

• 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 Killograms (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 \[Milliliters/Minutes\] 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (12)

Women's Health Care at Frost Street

San Diego, California, United States

Location

Children's Memorial Hospital

Chicago, Illinois, 60614, United States

Location

Medisphere Medical Research Center, LLC

Evansville, Indiana, 47714, United States

Location

Clayton Medical Research

St Louis, Missouri, 63117, United States

Location

Rochester Clinical Research, Inc.

Rochester, New York, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

Location

Westover Heights Clinic

Portland, Oregon, 97210, United States

Location

Primary Physicians Research, Inc

Pittsburgh, Pennsylvania, United States

Location

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

R/D Clinical Research, Inc

Lake Jackson, Texas, 77566, United States

Location

R/D Clinical Research

Lake Jackson, Texas, 77566, United States

Location

Related Publications (1)

• Block SL, Yogev R, Waldmeier F, Hamed K. Safety and pharmacokinetics of a single 1500-mg dose of famciclovir in adolescents with recurrent herpes labialis. Pediatr Infect Dis J. 2011 Jun;30(6):525-8. doi: 10.1097/INF.0b013e3182067cee.

  PMID: 21178655 DERIVED

Related Links

• NovartisClinicalTrials.com: pre-screening for this trial, view of a list of trials and participating study centers
• Adolescent Cold Sores Clinical Trial

MeSH Terms

Conditions

Herpes Labialis

Interventions

Famciclovir

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

Novartis.email@novartis.com

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2009
• First Posted: April 8, 2009
• Study Start: March 25, 2009
• Primary Completion: June 2, 2010
• Study Completion: June 2, 2010
• Last Updated: June 25, 2021
• Results First Posted: June 25, 2021

Record last verified: 2021-06

Locations

US (12)