Herpes LabialisPhase 2/3NCT00878072
Safety and Pharmacokinetics of Famciclovir Single 1500 mg Dose in Adolescents With Recurrent Herpes Labialis
A Phase 2/3 study testing Famciclovir in people with Herpes Labialis, run by Novartis Pharmaceuticals at 12 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Herpes Labialis
- What is being tested?
- Famciclovir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 12 sitesUnited States
- Study dates
- 25 Mar 2009to 2 Jun 2010
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Children's Memorial Hospital
Chicago, Illinois, 60614
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
University Hospitals Case Medical Center
Cleveland, Ohio, 44106
Medisphere Medical Research Center, LLC
Evansville, Indiana, 47714
Texas Children's Hospital
Houston, Texas, 77030
R/D Clinical Research, Inc
Lake Jackson, Texas, 77566
R/D Clinical Research
Lake Jackson, Texas, 77566
Primary Physicians Research, Inc
Pittsburgh, Pennsylvania
Westover Heights Clinic
Portland, Oregon, 97210
Rochester Clinical Research, Inc.
Rochester, New York
Women's Health Care at Frost Street
San Diego, California
Clayton Medical Research
St Louis, Missouri, 63117
About this study
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
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
Read the detailed description
Uncontrolled study
- Conditions
- Herpes Labialis
- Being tested
- Famciclovir
- Keywords
- Herpes labialis, cold sores, herpes simplex type 1
- Medical subject headings
- Herpes Labialis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FamciclovirDrug
Famciclovir 1500 mg (3 x 500 mg tablets) oral as a single dose.
| Study group | Role | What they receive |
|---|---|---|
| Famciclovir | Experimental | Not described Receives: Drug: Famciclovir |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 .
Measured: 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)
Tmax was defined as the time to reach maximum plasma concentration. Penciclovir (active metabolite from famciclovir) and 6-deoxypenciclovir (first intermediate metabolite from famciclovir) were determined by using a validated liquid chromatography/tandem mass spectrometry (LC/MS/MS) method. The limit of quantification was 0.15 microgram (µg)/milliliter (mL) for both compounds. Calculations were done in WinNonlin 5.0.1, using non-compartmental methods.
Measured: 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)
Cmax was defined as the maximum observed plasma concentration. Penciclovir (active metabolite from famciclovir) and 6-deoxypenciclovir (first intermediate metabolite from famciclovir) were determined by using LC/MS/MS method. The limit of quantification was 0.15 µg/mL for both compounds. Calculations were done in WinNonlin 5.0.1, using non-compartmental methods.
Measured: 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)
AUC 0-tlast was defined as the area under the plasma concentration-time curve from time zero up to the last quantifiable concentration (Clast) calculated by the linear trapezoidal rule. Penciclovir (active metabolite from famciclovir) and 6-deoxypenciclovir (first intermediate metabolite from famciclovir) were determined by using LC/MS/MS method. The limit of quantification was 0.15 µg/mL for both compounds. Calculations were done in WinNonlin 5.0.1, using non-compartmental methods.
Measured: 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)
AUC 0-infinity was defined as the area under the plasma concentration time curve from time zero to infinity = AUC 0-tlast + C last /λ z, where λz is the apparent elimination rate constant estimated by linear regression analysis of the terminal portion of the log-linear plasma concentration-time curve. Penciclovir (active metabolite from famciclovir) and 6-deoxypenciclovir (first intermediate metabolite from famciclovir) were determined by using LC/MS/MS method. The limit of quantification was 0.15 µg/mL for both compounds. Calculations were done in WinNonlin 5.0.1, using non-compartmental methods.
Measured: 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)
T½ was defined as the apparent terminal elimination half-life= ln 2/ λz. Penciclovir (active metabolite from famciclovir) and 6-deoxypenciclovir (first intermediate metabolite from famciclovir) were determined by using LC/MS/MS method. The limit of quantification was 0.15 µg/mL For both compounds. Calculations were done in WinNonlin 5.0.1, using non-compartmental methods.
Measured: Pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6 and 10 hours Post-dose
Apparent Oral Clearance of Penciclovir From Plasma (CL/F) of Penciclovir (Active Metabolite From Famciclovir)
CL/F was defined as the apparent oral clearance of penciclovir from plasma = dose of famciclovir*0.7884/AUC 0-inf, where 0.7884 is the ratio of the molecular weight of penciclovir (253.3 g/mol) to famciclovir (321.3 g/mol). F is the bioavailability of penciclovir after oral administration of famciclovir. Penciclovir (active metabolite from famciclovir) and 6-deoxypenciclovir (first intermediate metabolite from famciclovir) were determined by using LC/MS/MS method. The limit of quantification was 0.15 µg/mL for both compounds. Calculations were done in WinNonlin 5.0.1, using non-compartmental methods.
Measured: Pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6 and 10 hours Post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2009 (estimated)
- Study start25 Mar 2009
- Primary completion2 Jun 2010
- Study completion2 Jun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Herpes LabialisStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00878072
- Sponsor's protocol ID
- CFAM810B2305
- Status last verified
- Jun 2021
- First submitted
- 7 Apr 2009
- Last updated
- 25 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
Publications
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.
PubMed 21178655
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00878072
- Acronym / sponsor ID
- CFAM810B2305
- Conditions
- Herpes Labialis
- Keywords
- Herpes labialis, cold sores, herpes simplex type 1
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 25 Mar 2009
- Primary completion
- 2 Jun 2010 (actual)
- Study completion
- 2 Jun 2010 (actual)
- First posted
- 8 Apr 2009 (estimated)
- Results
- Posted 25 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Uncontrolled study
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Famciclovir | Experimental | Drug: Famciclovir |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FamciclovirFamciclovir 1500 mg (3 x 500 mg tablets) oral as a single dose. | Drug | Famciclovir |
Primary outcome
Number of Participants Reported Adverse Events (AEs), Serious Adverse Events (SAEs)
Time frame: From Start of the Study up to Day 36
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.
Number of Participants With Clinically Significant Laboratory Abnormalities
Time frame: From Start of the Study up to Day 36
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 .
6 secondary outcomes
Time of Maximum Observed Plasma Concentration (Tmax) of Penciclovir (Active Metabolite From Famciclovir) and 6-deoxypenciclovir (First Intermediate Metabolite From Famciclovir)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6 and 10 hours Post-dose
Apparent Oral Clearance of Penciclovir From Plasma (CL/F) of Penciclovir (Active Metabolite From Famciclovir)
Time frame: Pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6 and 10 hours Post-dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 21178655Block 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.
- NovartisClinicalTrials.com: pre-screening for this trial, view of a list of trials and participating study centersLink provided by the sponsor.
- Adolescent Cold Sores Clinical TrialLink provided by the sponsor.
Related trials for Herpes Labialis
RecruitingObservational study
Viral Infections in Healthy and Immunocompromised Hosts
Anogenital Herpes, COVID-19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Famciclovir in people with Herpes Labialis, run by Novartis Pharmaceuticals at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Reported Adverse Events (AEs), Serious Adverse Events (SAEs) (time frame: From Start of the Study up to Day 36). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00878072, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2021.