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

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo to BI 1026706; Drug: BI 1026706; Drug: Celecoxib; Drug: Pregabalin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02037165

1320.3

2012-005691-33 (EudraCT Number)

Details and patient eligibility

About

• 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

Enrollment: 25 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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25 participants in 5 patient groups

Test Treatment 1: BI 1026706

Experimental group

Description:

BI 1026706 plus matching placebo to BI 1026706 Powder for Oral Solution (PfOS) and placebo tablet

Treatment:

Drug: BI 1026706

Drug: Placebo to BI 1026706

Test Treatment 2: BI 1026706

Experimental group

Description:

BI 1026706 and placebo tablet

Treatment:

Drug: BI 1026706

Drug: Placebo to BI 1026706

Reference Treatment 1: BI 1026706

Experimental group

Description:

Matching placebo to BI 1026706 PfOS and placebo tablet

Treatment:

Drug: Placebo to BI 1026706

Reference Treatment 2: Celecoxib

Experimental group

Description:

Celecoxib hard capsule as active comparator plus matching placebo to BI 1026706 PfOS

Treatment:

Drug: Placebo to BI 1026706

Drug: Celecoxib

Reference Treatment 3: Pregabalin

Experimental group

Description:

Pregabalin hard capsule as active comparator plus matching placebo to BI 1026706 PfOS

Treatment:

Drug: Pregabalin

Drug: Placebo to BI 1026706