Effectiveness and Safety of Different Doses of BI 1026706 in Patients With Postoperative Dental Pain

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 tests
• Age 18 to 55 years (incl.)
• Body Mass Index 18.5 to 29.9 kg/m2 (incl.)
• Patients scheduled for removal of one mandibular third molar with partial or complete bony impaction. If medically indicated, the ipsilateral third molar in the upper jaw could also be removed;
• Surgery will be conducted under local anaesthesia using 12% lidocaine (with epinephrine). Intravenous sedations and general anaesthetics are not permitted.
• Reliable, cooperative, and of adequate intelligence to record the requested information on the analgesic questionnaire form
• Examined by the attending oral surgeon or physician and medically cleared to participate in the study
• Scheduled to undergo a qualifying surgical procedure
• 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 Blod 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
• Acute local infection at the time of surgery that could confound the post-surgical evaluation
• 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)