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
- Conditions
- Healthy
- Interventions
- Registration Number
- NCT02037165
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
* 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 25
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Test Treatment 1: BI 1026706 Placebo to BI 1026706 BI 1026706 plus matching placebo to BI 1026706 Powder for Oral Solution (PfOS) and placebo tablet Test Treatment 2: BI 1026706 BI 1026706 BI 1026706 and placebo tablet Reference Treatment 1: BI 1026706 Placebo to BI 1026706 Matching placebo to BI 1026706 PfOS and placebo tablet Reference Treatment 2: Celecoxib Placebo to BI 1026706 Celecoxib hard capsule as active comparator plus matching placebo to BI 1026706 PfOS Reference Treatment 3: Pregabalin Pregabalin Pregabalin hard capsule as active comparator plus matching placebo to BI 1026706 PfOS Test Treatment 2: BI 1026706 Placebo to BI 1026706 BI 1026706 and placebo tablet Reference Treatment 3: Pregabalin Placebo to BI 1026706 Pregabalin hard capsule as active comparator plus matching placebo to BI 1026706 PfOS Test Treatment 1: BI 1026706 BI 1026706 BI 1026706 plus matching placebo to BI 1026706 Powder for Oral Solution (PfOS) and placebo tablet Reference Treatment 2: Celecoxib Celecoxib Celecoxib hard capsule as active comparator plus matching placebo to BI 1026706 PfOS
- Primary Outcome Measures
Name Time Method Overall Peak-to-Peak(PtP) N2/P2-component Amplitude of Laser (Somatosensory/Radiant Heat) Evoked Potentials (LEP) in Ultraviolet B (UVB) -Irradiated Skin 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)
- Secondary Outcome Measures
Name Time Method 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]) Electronic Visual Analogue Scale (100mm VAS "Post Laser Pain" scales) - measured in the UVB-irradiated skin type, where 0mm = 'no pain' and 100mm = 'severe pain'.
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]) Overall Peak-to-Peak (PtP) N2/P2-component amplitude of (LEP) in capsaicin-irritated skin.
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 "peripheral" N2-component amplitudes - measured in capsaicin-irritated skin type.
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]) Single "central" P2-component amplitudes - measured in capsaicin-irritated skin type.
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]) Weighted needle (pain) threshold (WNT) in the secondary flare area of capsaicin-irritated skin. The weighted needle (pain) threshold (WNT) will be determined (with regard to investigation of mechanical hyperalgesia in the secondary hyperalgesia zone around the primary capsaicin application zone) by fixed weight steps - contact made by "rounded" needle tip to skin (ranging from 1 mN to 512 mN).
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]) Single "central" P2-component amplitudes - measured in UVB-irradiated skin type.
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]) Electronic Visual Analogue Scale (100mm VAS "Post Laser Pain" scales) - measured in the capsaicin-irritated skin type, where 0mm = 'no pain' and 100mm = 'severe pain'.
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]) Single "peripheral" N2-component amplitudes - measured in UVB-irradiated skin type.
Trial Locations
- Locations (1)
1320.3.1 Boehringer Ingelheim Investigational Site
🇩🇪Dornach, Germany