A Phase 1, Open Label, Randomized, Three-treatment, Three-sequence, Three-period, Crossover Adhesion Performance and Pharmacokinetic Study of Lidocaine Topical System 1.8% in Healthy, Adult Subjects Under Normal and Two Water Stress Conditions
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Mean cumulative adhesion score
研究概览
简要总结
The objectives of this study are to evaluate the adhesion performance and pharmacokinetics of ZTlido (lidocaine topical system) 1.8% during swimming, showering, and under normal conditions.
详细描述
In this Phase 1, open-label, three-period crossover study, 24 healthy, adult male and female subjects are randomized to 1 of 3 treatment sequences. During each treatment period, subjects have one lidocaine topical system applied to their back for 12 hours with a 4-day washout between treatments. In each treatment period, the subject will either swim (Treatment A), shower (Treatment B), or refrain from these activities (Treatment C) while wearing the topical system. Blood samples for lidocaine PK will be collected pre-dose until 24 hours. Adhesion will be monitored throughout the wear time and skin irritation will be assessed the topical system is removed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must be healthy based on medical history, laboratory work, and physical exam
- •Body mass index ranging between 18.0-30.0 kg/m2, inclusive
- •Capable of unaided swimming
- •If childbearing potential, use of acceptable form of birth control
- •In case of females of childbearing potential, have a negative serum pregnancy
排除标准
- •Allergy or known hypersensitivity to lidocaine, amide-type local anesthetics or any component of the product formulation
- •Any major medical illness 3 months prior or any significant history or ongoing chronic medical illness affecting the major body systems, including the skin
- •Subjects with conditions that might affect application of the product or its adhesive properties (including psoriasis, eczema, atopic dermatitis, damaged or irritated epidermal layer, and excessive hair or oil on the skin)
- •Use of antiarrhymthic drugs (such as tocainide and mexiletine) and local anesthetics within 14 days prior to product application.
- •History of addiction, abuse, or misuse of any drug
- •Use of nicotine-containing products within 30 days
研究组 & 干预措施
Lidocaine topical system with swimming (Treatment A)
One topical system is applied to the mid- to upper-back for 12 hours. Subjects swim for 15 minutes in a heated pool 4 hours after topical system application.
干预措施: Lidocaine topical system 1.8% (Drug)
Lidocaine topical system with showering (Treatment B)
One topical system is applied to the mid- to upper-back for 12 hours. Subjects take a 10-minute shower 8 hours after topical system application.
干预措施: Lidocaine topical system 1.8% (Drug)
Lidocaine topical system under normal conditions (Treatment C)
One topical system is applied to the mid- to upper-back for 12 hours. Topical systems are not exposed to water during this period.
干预措施: Lidocaine topical system 1.8% (Drug)
结局指标
主要结局
Mean cumulative adhesion score
时间窗: Over 12 hours
Adhesion to skin assessed by FDA 0-4 scoring system. The scoring for adhesion of patches is indicated as follows: 0 = ≥ 90% Adhered (essentially no lift off the skin), 1 = ≥ 75% to \< 90% Adhered (some edges only lifting off the skin), 2 = ≥ 50% to \< 75% Adhered (less than half of the patch lifting off the skin), \> 0% to \< 50% Adhered but not detached (more than half of the patch lifting off the skin without falling off), and 4 = 0% adhered (patched completely detached). The cumulative adhesion score is calculated as the sum of scores at each assessment time point (3, 4.5, 7, 8.5, and 12 hours).
次要结局
- Area under the plasma concentration-time curve (AUC) from Time 0 to Time 24 hours(0, 1.5, 3.0, 6.0, 9.0, 12.0, 15.0, 18.0, 24.0 hours post-dose)
- Area under the plasma concentration-time curve (AUC) from Time 0 to Time Infinity(0, 1.5, 3.0, 6.0, 9.0, 12.0, 15.0, 18.0, 24.0 hours post-dose)
- Peak plasma concentration (Cmax) of lidocaine(0, 1.5, 3.0, 6.0, 9.0, 12.0, 15.0, 18.0, 24.0 hours post-dose)
- Dermal Response Score(12.5 and 14 hours post-dose)