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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 12
- 主要终点
- Number of Participants Reported Adverse Events (AEs), Serious Adverse Events (SAEs)
研究概览
简要总结
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
详细描述
Uncontrolled study
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Famciclovir
干预措施: Famciclovir (Drug)
结局指标
主要结局
Number of Participants Reported Adverse Events (AEs), Serious Adverse Events (SAEs)
时间窗: 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
时间窗: 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 .
次要结局
- 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)
- 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)