Safety and Pharmacokinetics of Famciclovir Single 1500 mg Dose in Adolescents With Recurrent Herpes Labialis
Information source: Novartis
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Herpes Labialis
Intervention: Famciclovir (Drug)
Phase: Phase 2/Phase 3
Status: Recruiting
Sponsored by: Novartis Pharmaceuticals Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis Pharmaceuticals
Overall contact:
Rima Hallik, Phone: (905) 826-2695
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
Clinical Details
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
Study design: Treatment, Open Label, Single Group Assignment
Primary outcome: Safety: Frequency of adverse events and laboratory abnormalities
Secondary outcome: Pharmacokinetics: Measure: AUC0-tlast (area under the penciclovir concentration-time curve from time zero to the last measurable timepoint)Pharmacokinetics: Measure: AUC0-∞ (area under the penciclovir concentration-time curve from time zero to infinity) Pharmacokinetics: Measure: Cmax (maximum observed plasma concentration of penciclovir post-dose) Pharmacokinetics: Measure: CL/F (apparent oral clearance of penciclovir) Pharmacokinetics: Measure: Tmax (time of maximum observed plasma concentration of penciclovir)
Eligibility
Minimum age: 12 Years.
Maximum age: 18 Years.
Gender(s): Both.
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.
Locations and Contacts
Rima Hallik, Phone: (905) 826-2695
Children's Memorial Hospital, Chicago, Illinois 60614, United States; Recruiting
Ram Yogev, MD, Phone: 773-880-4757, Email: ryogev@childrensmemorial.org
Medisphere Medical Research Center, LLC, Evansville, Indiana 47714, United States; Not yet recruiting
Steven Elliott, MD, Phone: 812-471-4110, Email: awathen@medisphereresearch.com
Clayton Medical Research, St. Louis, Missouri 63117, United States; Recruiting
Mohammed Abudalu, MD, Phone: 314-647-5754, Email: claytonresearchinstitute@yahoo.com
Facility: University Hospitals Case Medical Center, Cleveland, Ohio 44106, United States; Withdrawn
Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio 45229, United States; Not yet recruiting
Michael Spigarelli, MD, Phone: 513-636-8597, Email: michael.spigarelli@cchmc.org
Westover Heights Clinic, Portland, Oregon 97210, United States; Not yet recruiting
Helen Henry, MD, Phone: 503-226-6678, Email: basak@westoverheights.com
Texas Children's Hospital, Houston, Texas 77030, United States; Not yet recruiting
Lisa Bomgaars, MD, Phone: 832-824-4588, Email: lbomgaars@txccc.org
R/D Clinical Research, Inc, Lake Jackson, Texas 77566, United States; Recruiting
Harvey Resnick, MD, Phone: 979-297-3535, Email: mail@rdclinicalresearch.com
R/D Clinical Research, Lake Jackson, Texas 77566, United States; Recruiting
Brian Feaver, MD, Phone: 979-299-0403, Email: mail@rdclinicalresearch.com
Additional Information
Starting date: March 2009
Last updated: May 8, 2009
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