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

Study Overview
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Brief Summary
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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

Official Title
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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)

Conditions
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Healthy

Intervention / Treatment
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* Drug: Placebo to BI 1026706
* Drug: Pregabalin
* Drug: BI 1026706
* Drug: Celecoxib


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Healthy males according to the investigator's assessment, as based on the following criteria: a complete medical history including a physical examination, vital signs (Blood Pressure, Pulse Rate), 12-lead electrocardiogram, and clinical laboratory Age 18 to 55 years (incl.) BMI (Body Mass Index) 18.5 to 29.9 kg/m2 (incl.) Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation Exclusion criteria: Any finding in the medical examination (including Blood Pressure, Pulse Rate or Electrocardiogram) deviating from normal and judged clinically relevant by the investigator Repeated measurement of systolic blood pressure greater than 140 mm Hg or diastolic blood pressure greater than 90 mm Hg Any laboratory value outside the reference range that the investigator considers to be of clinical relevance Any evidence of a concomitant disease judged clinically relevant by the investigator Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders Surgery of the gastrointestinal tract that could interfere with kinetics of the study drug(s) Diseases of the central nervous system (such as epilepsy), other neurological disorders or psychiatric disorders

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test Treatment 1: BI 1026706<br>BI 1026706 plus matching placebo to BI 1026706 Powder for Oral Solution (PfOS) and placebo tablet | Drug: Placebo to BI 1026706<br>* Placebo tablet<br>Drug: BI 1026706<br>* BI 1026706 oral solution<br>|
| Experimental: Test Treatment 2: BI 1026706<br>BI 1026706 and placebo tablet | Drug: Placebo to BI 1026706<br>* Placebo tablet<br>Drug: BI 1026706<br>* BI 1026706 oral solution<br>|
| Experimental: Reference Treatment 1: BI 1026706<br>Matching placebo to BI 1026706 PfOS and placebo tablet | Drug: Placebo to BI 1026706<br>* Placebo tablet<br>|
| Experimental: Reference Treatment 2: Celecoxib<br>Celecoxib hard capsule as active comparator plus matching placebo to BI 1026706 PfOS | Drug: Placebo to BI 1026706<br>* Placebo tablet<br>Drug: Celecoxib<br>* Celecoxib hard capsule<br>|
| Experimental: Reference Treatment 3: Pregabalin<br>Pregabalin hard capsule as active comparator plus matching placebo to BI 1026706 PfOS | Drug: Placebo to BI 1026706<br>* Placebo tablet<br>Drug: Pregabalin<br>* Pregabalin hard capsule<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Peak-to-Peak(PtP) N2/P2-component Amplitude of Laser (Somatosensory/Radiant Heat) Evoked Potentials (LEP) in Ultraviolet B (UVB) -Irradiated Skin | Overall Peak-to-Peak (PtP) N2/P2-component amplitude of Laser (somatosensory/radiant heat) evoked potentials (LEP) in UVB-irradiated skin. Treated set (TS) | 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]) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Peak-to-Peak (PtP) N2/P2-component Amplitude of (LEP) in Capsaicin-irritated Skin | 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 UVB-irradiated Skin Type | 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 Capsaicin-irritated Skin Type | 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 UVB-irradiated Skin Type | 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 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]) | 
| Electronic Visual Analogue Scale (VAS) (100mm VAS Post Laser Pain Scales) - Measured in the UVB-irradiated Skin Type | 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'. | 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. | 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'. | 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 | 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). | 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]) |