A Phase 1, Investigator And Subject Blind (Sponsor Open), Randomized, Placebo Controlled, Parallel Cohort, Escalating Multiple Dose Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of A Varenicline Transdermal Delivery System In Adult Smokers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Area under the plasma concentration-time curve (AUC24); observed maximum plasma concentration (Cmax) in a given dosing interval and time of maximum plasma concentration (Tmax)
研究概览
简要总结
This study will evaluate the steady-state pharmacokinetics, safety and tolerability of a varenicline patch applied once daily to the skin for 14 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •male or female
- •adult cigarette smokers of any race
排除标准
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- •Subjects with active suicidal ideation or suicidal behavior within 1 year prior to Screening as determined through the use of the C-SSRS (Columbia-Suicide Severity Rating Scale) or active ideation identified at Screening or Day
- •Any condition possibly affecting drug absorption through the skin (eg, psoriasis).
研究组 & 干预措施
Cohort 1
干预措施: varenicline free base patch (Drug)
Cohort 2
干预措施: varenicline free base patch (Drug)
Cohort 2
干预措施: placebo patch (Drug)
Cohort 3
干预措施: varenicline free base patch (Drug)
Cohort 3
干预措施: placebo patch (Drug)
Cohort 4
干预措施: varenicline free base patch (Drug)
Cohort 4
干预措施: placebo patch (Drug)
结局指标
主要结局
Area under the plasma concentration-time curve (AUC24); observed maximum plasma concentration (Cmax) in a given dosing interval and time of maximum plasma concentration (Tmax)
时间窗: Days 1, 7 and 14
Observed accumulation ratio (Rac)
时间窗: Days 7 and 14
Observed minimum plasma concentration (Cmin) in a given dosing interval, and peak: trough fluctuation (PTF)
时间窗: Days 7 and 14
Terminal half life (t1/2)
时间窗: Day 14-Day 19
次要结局
- Dermal rating scores (as measured by the Rating Scale for Assessment of Application Site Dermal-Erythema, Edema and Irritation)(Days 1-14 (24 hpd); Days 1, 7-8 (1 and 12 hpd); Day 14 (1,6,12,24,48,72,96 and 120 hpd))
- VAS scores for nausea (using a Visual Analog Scale)(Days 1-19 (daily))
- Daily adhesion score (as measured by the Rating Scale for Adhesion)(Days 1-14 (12 and 24 hpd);Days 1, 7 and 14 (1 and 6 hpd))