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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

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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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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