Effectiveness of Two Different Doses of BI 1026706 on the Overall Peak-to-Peak (PtP) N2/P2-component Amplitude of Laser (Somatosensory, Radiant-heat) Evoked Potentials (LEP) in UVB (Ultraviolet)-Irradiated Skin in Healthy Male Volunteers (a Single-blinded, Randomised, Placebo-controlled, Single-dose, Five-way Crossover Study)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Overall Peak-to-Peak(PtP) N2/P2-component Amplitude of Laser (Somatosensory/Radiant Heat) Evoked Potentials (LEP) in Ultraviolet B (UVB) -Irradiated Skin
研究概览
简要总结
- To investigate the influence of different doses of BI 1026706 on the primary endpoint (PtP-amplitude LEP in UV skin) compared to placebo.
- The comparison of both doses of BI 1026706 to celecoxib in the UVB treatment.
- Comparison of both doses of BI 1026706 to placebo and pregabalin in the capsaicin treatment
- Exploration of the pharmacokinetics of BI 1026706
- Exploration of safety and tolerability of BI 1026706
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
- Single
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Test Treatment 2: BI 1026706
BI 1026706 and placebo tablet
干预措施: Placebo to BI 1026706 (Drug)
Test Treatment 1: BI 1026706
BI 1026706 plus matching placebo to BI 1026706 Powder for Oral Solution (PfOS) and placebo tablet
干预措施: Placebo to BI 1026706 (Drug)
Test Treatment 1: BI 1026706
BI 1026706 plus matching placebo to BI 1026706 Powder for Oral Solution (PfOS) and placebo tablet
干预措施: BI 1026706 (Drug)
Test Treatment 2: BI 1026706
BI 1026706 and placebo tablet
干预措施: BI 1026706 (Drug)
Reference Treatment 1: BI 1026706
Matching placebo to BI 1026706 PfOS and placebo tablet
干预措施: Placebo to BI 1026706 (Drug)
Reference Treatment 2: Celecoxib
Celecoxib hard capsule as active comparator plus matching placebo to BI 1026706 PfOS
干预措施: Placebo to BI 1026706 (Drug)
Reference Treatment 2: Celecoxib
Celecoxib hard capsule as active comparator plus matching placebo to BI 1026706 PfOS
干预措施: Celecoxib (Drug)
Reference Treatment 3: Pregabalin
Pregabalin hard capsule as active comparator plus matching placebo to BI 1026706 PfOS
干预措施: Placebo to BI 1026706 (Drug)
Reference Treatment 3: Pregabalin
Pregabalin hard capsule as active comparator plus matching placebo to BI 1026706 PfOS
干预措施: Pregabalin (Drug)
结局指标
主要结局
Overall Peak-to-Peak(PtP) N2/P2-component Amplitude of Laser (Somatosensory/Radiant Heat) Evoked Potentials (LEP) in Ultraviolet B (UVB) -Irradiated Skin
时间窗: up to 24 hours (h): -2:05h, 0:30h, 1:00h, 2:00h, 3:00h, 4:00h, 5:00h, 6:00h, 22:00h, 24:00h (relative to study drug administration [h:min])
Overall Peak-to-Peak (PtP) N2/P2-component amplitude of Laser (somatosensory/radiant heat) evoked potentials (LEP) in UVB-irradiated skin. Treated set (TS)
次要结局
- Electronic Visual Analogue Scale (VAS) (100mm VAS "Post Laser Pain" Scales) - Measured in the UVB-irradiated Skin Type(up to 24 hours(h): -2:05h, 0:30h, 1:00h, 2:00h, 3:00h, 4:00h, 5:00h, 6:00h, 22:00h, 24:00h (relative to study drug administration [h:min]))
- Overall Peak-to-Peak (PtP) N2/P2-component Amplitude of (LEP) in Capsaicin-irritated Skin(up to 24 hours(h): -1:20h, 0:30h, 1:00h, 2:00h, 3:00h, 4:00h, 5:00h, 6:00h, 22:00h, 24:00h (relative to study drug administration [h:min]))
- Single "Peripheral" N2-component Amplitudes - Measured in Capsaicin-irritated Skin Type(up to 24 hours(h): -1:20h, 0:30h, 1:00h, 2:00h, 3:00h, 4:00h, 5:00h, 6:00h, 22:00h, 24:00h (relative to study drug administration [h:min]))
- Single "Central" P2-component Amplitudes - Measured in Capsaicin-irritated Skin Type(up to 24 hours(h): -1:20h, 0:30h, 1:00h, 2:00h, 3:00h, 4:00h, 5:00h, 6:00h, 22:00h, 24:00h (relative to study drug administration [h:min]))
- Weighted Needle (Pain) Threshold (WNT) in the Secondary Flare Area of Capsaicin-irritated Skin(up to 24 hours(h): -1:20h, 0:30h, 1:00h, 2:00h, 3:00h, 4:00h, 5:00h, 6:00h, 22:00h, 24:00h (relative to study drug administration [h:min]))
- Single "Central" P2-component Amplitudes - Measured in UVB-irradiated Skin Type(up to 24 hours(h): -2:05h, 0:30h, 1:00h, 2:00h, 3:00h, 4:00h, 5:00h, 6:00h, 22:00h, 24:00h (relative to study drug administration [h:min]))
- Electronic Visual Analogue Scale (100mm VAS "Post Laser Pain" Scales) - Measured in the Capsaicin-irritated Skin Type.(up to 24 hours(h): -1:20h, 0:30h, 1:00h, 2:00h, 3:00h, 4:00h, 5:00h, 6:00h, 22:00h, 24:00h (relative to study drug administration [h:min]))
- Single "Peripheral" N2-component Amplitudes - Measured in UVB-irradiated Skin Type(up to 24 hours(h): -2:05h, 0:30h, 1:00h, 2:00h, 3:00h, 4:00h, 5:00h, 6:00h, 22:00h, 24:00h (relative to study drug administration [h:min]))