Phase 1
Completed N=25
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
Healthy
Source: ClinicalTrials.gov NCT02037165 ↗
Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Jul 2019
Primary outcomePrimary: Overall Peak-to-Peak(PtP) N2/P2-component Amplitude of Laser (Somatosensory/Radiant Heat) Evoked Potentials (LEP) in Ultraviolet B (UVB) -Irradiated Skin — 29.22; 26.08; 28.93; 26.35 Microvolts (µv)
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Peak-to-Peak(PtP) N2/P2-component Amplitude of Laser (Somatosensory/Radiant Heat) Evoked Potentials (LEP) in Ultraviolet B (UVB) -Irradiated Skin |
29.22; 26.08; 28.93; 26.35; 27.84; 28.00 | — |
| SECONDARY Overall Peak-to-Peak (PtP) N2/P2-component Amplitude of (LEP) in Capsaicin-irritated Skin |
21.17; 18.53; 19.57; 22.44; 27.21; 25.00 | — |
| SECONDARY Single "Peripheral" N2-component Amplitudes - Measured in UVB-irradiated Skin Type |
14.62; 12.78; 14.25; 13.45; 14.48; 13.77 | — |
| SECONDARY Single "Peripheral" N2-component Amplitudes - Measured in Capsaicin-irritated Skin Type |
10.42; 9.65; 9.27; 10.99; 13.95; 12.73 | — |
| SECONDARY Single "Central" P2-component Amplitudes - Measured in UVB-irradiated Skin Type |
14.59; 13.31; 14.68; 12.90; 14.06; 14.23 | — |
| SECONDARY Single "Central" P2-component Amplitudes - Measured in Capsaicin-irritated Skin Type |
10.75; 8.88; 10.30; 11.45; 13.83; 12.27 | — |
| SECONDARY Electronic Visual Analogue Scale (VAS) (100mm VAS "Post Laser Pain" Scales) - Measured in the UVB-irradiated Skin Type |
30.40; 28.42; 30.16; 35.08; 39.24; 32.46 | — |
| SECONDARY Electronic Visual Analogue Scale (100mm VAS "Post Laser Pain" Scales) - Measured in the Capsaicin-irritated Skin Type. |
18.64; 16.79; 20.36; 22.60; 30.64; 25.96 | — |
| SECONDARY Weighted Needle (Pain) Threshold (WNT) in the Secondary Flare Area of Capsaicin-irritated Skin |
348.72; 366.65; 369.98; 347.12; 312.88; 295.65 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02037165). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.