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Completed

NCT Number: NCT02037165

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

* 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

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

1320.3.1 Boehringer Ingelheim Investigational Site

Dörnach, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo to BI 1026706

Drug

Placebo tablet

Pregabalin

Drug

Pregabalin hard capsule

BI 1026706

Drug

BI 1026706 oral solution

Celecoxib

Drug

Celecoxib hard capsule

Primary outcomes

  1. Overall Peak-to-Peak(PtP) N2/P2-component Amplitude of Laser (Somatosensory/Radiant Heat) Evoked Potentials (LEP) in Ultraviolet B (UVB) -Irradiated Skin

    Time frame: 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 outcomes

  1. Overall Peak-to-Peak (PtP) N2/P2-component Amplitude of (LEP) in Capsaicin-irritated Skin

    Time frame: 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.

  2. Single "Peripheral" N2-component Amplitudes - Measured in UVB-irradiated Skin Type

    Time frame: 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.

  3. Single "Peripheral" N2-component Amplitudes - Measured in Capsaicin-irritated Skin Type

    Time frame: 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.

  4. Single "Central" P2-component Amplitudes - Measured in UVB-irradiated Skin Type

    Time frame: 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.

  5. Single "Central" P2-component Amplitudes - Measured in Capsaicin-irritated Skin Type

    Time frame: 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.

  6. Electronic Visual Analogue Scale (VAS) (100mm VAS "Post Laser Pain" Scales) - Measured in the UVB-irradiated Skin Type

    Time frame: 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'.

  7. Electronic Visual Analogue Scale (100mm VAS "Post Laser Pain" Scales) - Measured in the Capsaicin-irritated Skin Type.

    Time frame: 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'.

  8. Weighted Needle (Pain) Threshold (WNT) in the Secondary Flare Area of Capsaicin-irritated Skin

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

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)

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jan 15, 2014
Registry last updated
Jul 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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