Trial · NCT00878072
Safety and Pharmacokinetics of Famciclovir Single 1500 mg Dose in Adolescents With Recurrent Herpes Labialis
NCT00878072, Phase 2, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2021-06-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Pharmacokinetics of Famciclovir Single 1500 mg Dose in Adolescents With Recurrent Herpes Labialis. Trials, record NCT00878072. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00878072
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Pharmacokinetics of Famciclovir Single 1500 mg Dose in Adolescents With Recurrent Herpes Labialis
- NCT number
- NCT00878072
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 53 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Herpes Labialis
- Interventions
- Famciclovir
- First posted
- 2009-04-08
- Last updated
- 2021-06-25
- Results first posted
- 2021-06-25
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Reported Adverse Events (AEs), Serious Adverse Events (SAEs) | 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. |
| Primary | Number of Participants With Clinically Significant Laboratory Abnormalities | 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 . |
| Secondary | 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 | 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. |
| Secondary | 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 | 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. |
| Secondary | 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 | 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. |
| Secondary | 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 | 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. |
| Secondary | 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 | 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. |
| Secondary | Apparent Oral Clearance of Penciclovir From Plasma (CL/F) of Penciclovir (Active Metabolite From Famciclovir) | Pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6 and 10 hours Post-dose | 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. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Reported Adverse Events (AEs), Serious Adverse Events (SAEs) | From Start of the Study up to Day 36 | The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Clinically Significant Laboratory Abnormalities | From Start of the Study up to Day 36 | The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 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 | The analysis was performed in PK (Pharmacokinetics) analysis set (PAS) population, defined as all participants who participated in the PK assessment part and who did not miss more than one PK blood sampling. Here, number of participants analyzed refer to the number of participants evaluable for this outcome at specified time point. | Hours | MEDIAN |
| SECONDARY | 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 | The analysis was performed in PK (Pharmacokinetics) analysis set (PAS) population, defined as all participants who participated in the PK assessment part and who did not miss more than one PK blood sampling. Here, number of participants analyzed refer to the number of participants evaluable for this outcome at specified time point. | Microgram (µg)/milliliter(mL) | MEAN |
| SECONDARY | 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 | The analysis was performed in PK (Pharmacokinetics) analysis set (PAS) population, defined as all participants who participated in the PK assessment part and who did not miss more than one PK blood sampling. Here, number of participants analyzed refer to the number of participants evaluable for this outcome at specified time point. | Microgram(µg)/Milliliter(mL)*Hour(h) | MEAN |
| SECONDARY | 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 | The analysis was performed in PK (Pharmacokinetics) analysis set (PAS) population, defined as all participants who participated in the PK assessment part and who did not miss more than one PK blood sampling. Here, number of participants analyzed refer to the number of participants evaluable for this outcome at specified time point. | Microgram(µg)/Milliliter(mL)*Hour(h) | MEAN |
| SECONDARY | 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 | The analysis was performed in PK (Pharmacokinetics) analysis set (PAS) population, defined as all participants who participated in the PK assessment part and who did not miss more than one PK blood sampling. Here, number of participants analyzed refer to the number of participants evaluable for this outcome at specified time point. | Hours | MEAN |
| SECONDARY | Apparent Oral Clearance of Penciclovir From Plasma (CL/F) of Penciclovir (Active Metabolite From Famciclovir) | Pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6 and 10 hours Post-dose | The analysis was performed in PK (Pharmacokinetics) analysis set (PAS) population, defined as all participants who participated in the PK assessment part and who did not miss more than one PK blood sampling. Here, number of participants analyzed refer to the number of participants evaluable for this outcome at specified time point. | Litres(L)/Hour(h) | MEAN |
Source ClinicalTrials.gov
Results by group21
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Reported Adverse Events (AEs), Serious Adverse Events (SAEs) | Famciclovir (Participants Aged 12 to Less Than [<] 15 Years) | Adverse Events | 6 | Participants | |
| Number of Participants Reported Adverse Events (AEs), Serious Adverse Events (SAEs) | Famciclovir (Participants Aged 15 to Less Than [<] 18 Years) | Adverse Events | 6 | Participants | |
| Number of Participants Reported Adverse Events (AEs), Serious Adverse Events (SAEs) | Famciclovir (Participants Aged 12 to Less Than [<] 15 Years) | Serious Adverse Events | 0 | Participants | |
| Number of Participants Reported Adverse Events (AEs), Serious Adverse Events (SAEs) | Famciclovir (Participants Aged 15 to Less Than [<] 18 Years) | Serious Adverse Events | 0 | Participants | |
| Number of Participants With Clinically Significant Laboratory Abnormalities | Famciclovir (Participants Aged 12 to Less Than [<] 15 Years) | Hematology | 0 | Participants | |
| Number of Participants With Clinically Significant Laboratory Abnormalities | Famciclovir (Participants Aged 15 to Less Than [<] 18 Years) | Hematology | 0 | Participants | |
| Number of Participants With Clinically Significant Laboratory Abnormalities | Famciclovir (Participants Aged 12 to Less Than [<] 15 Years) | Clinical chemistry | 0 | Participants | |
| Number of Participants With Clinically Significant Laboratory Abnormalities | Famciclovir (Participants Aged 15 to Less Than [<] 18 Years) | Clinical chemistry | 0 | Participants | |
| Number of Participants With Clinically Significant Laboratory Abnormalities | Famciclovir (Participants Aged 12 to Less Than [<] 15 Years) | Urinalysis | 0 | Participants | |
| Number of Participants With Clinically Significant Laboratory Abnormalities | Famciclovir (Participants Aged 15 to Less Than [<] 18 Years) | Urinalysis | 0 | Participants |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Famciclovir | 53 | |
| Overall Study | COMPLETED | Famciclovir | 51 | |
| Overall Study | NOT COMPLETED | Famciclovir | 2 |
Source ClinicalTrials.gov
Adverse events36
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Famciclovir (Participants Aged 12 to Less Than [<] 15 Years) | 0 | 28 | |
| other | Anaemia | Blood and lymphatic system disorders | Famciclovir (Participants Aged 15 to Less Than [<] 18 Years) | 1 | 25 | |
| other | Anaemia | Blood and lymphatic system disorders | Famciclovir | 1 | 53 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Famciclovir (Participants Aged 12 to Less Than [<] 15 Years) | 0 | 28 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Famciclovir (Participants Aged 15 to Less Than [<] 18 Years) | 1 | 25 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Famciclovir | 1 | 53 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Famciclovir (Participants Aged 12 to Less Than [<] 15 Years) | 1 | 28 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Famciclovir (Participants Aged 15 to Less Than [<] 18 Years) | 0 | 25 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Famciclovir | 1 | 53 | |
| other | Diarrhoea | Gastrointestinal disorders | Famciclovir (Participants Aged 12 to Less Than [<] 15 Years) | 1 | 28 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Famciclovir (Participants Aged 12 to Less Than [<] 15 Years) | 0 | 28 |
| Total, all-cause mortality | Famciclovir (Participants Aged 15 to Less Than [<] 18 Years) | 0 | 25 |
| Total, all-cause mortality | Famciclovir | 0 | 53 |
| Total, other adverse events | Famciclovir (Participants Aged 12 to Less Than [<] 15 Years) | 6 | 28 |
| Total, other adverse events | Famciclovir (Participants Aged 15 to Less Than [<] 18 Years) | 6 | 25 |
| Total, other adverse events | Famciclovir | 12 | 53 |
| Total, serious adverse events | Famciclovir (Participants Aged 12 to Less Than [<] 15 Years) | 0 | 28 |
| Total, serious adverse events | Famciclovir (Participants Aged 15 to Less Than [<] 18 Years) | 0 | 25 |
| Total, serious adverse events | Famciclovir | 0 | 53 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 21178655 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00878072
GET https://conductscience.org/api/trials/v1/NCT00878072/results?page=2