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

• Status: Completed
• Trial end date: 2014-04-15
• Target enrollment: 0
• Participant gender: Male

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Celecoxib; Pregabalin

Criteria

Inclusion criteria:

1. 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

2. Age 18 to 55 years (incl.)

3. BMI (Body Mass Index) 18.5 to 29.9 kg/m2 (incl.)

4. Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation

Exclusion criteria:

1. Any finding in the medical examination (including Blood Pressure, Pulse Rate or Electrocardiogram) deviating from normal and judged clinically relevant by the investigator

2. Repeated measurement of systolic blood pressure greater than 140 mm Hg or diastolic blood pressure greater than 90 mm Hg

3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance

4. Any evidence of a concomitant disease judged clinically relevant by the investigator

5. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders

6. Surgery of the gastrointestinal tract that could interfere with kinetics of the study drug(s)

7. Diseases of the central nervous system (such as epilepsy), other neurological disorders or psychiatric disorders