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

NCT02037165 | Completed Phase 1 Results

• 2 other identifiers: 1320.32012-005691-33
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Healthy

Outcome Measures

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

  Overall Peak-to-Peak (PtP) N2/P2-component amplitude of Laser (somatosensory/radiant heat) evoked potentials (LEP) in UVB-irradiated skin. Treated set (TS)

  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])

Secondary Outcomes (8)

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

  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 UVB-irradiated Skin Type

  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 Capsaicin-irritated Skin Type

  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 UVB-irradiated Skin Type

  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 Capsaicin-irritated Skin Type

  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])

Study Arms (5)

Test Treatment 1: BI 1026706

EXPERIMENTAL

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

Drug: Placebo to BI 1026706; Drug: BI 1026706

Test Treatment 2: BI 1026706

EXPERIMENTAL

BI 1026706 and placebo tablet

Drug: Placebo to BI 1026706; Drug: BI 1026706

Reference Treatment 1: BI 1026706

EXPERIMENTAL

Matching placebo to BI 1026706 PfOS and placebo tablet

Drug: Placebo to BI 1026706

Reference Treatment 2: Celecoxib

EXPERIMENTAL

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

Drug: Placebo to BI 1026706; Drug: Celecoxib

Reference Treatment 3: Pregabalin

EXPERIMENTAL

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

Drug: Placebo to BI 1026706; Drug: Pregabalin

Interventions

Placebo to BI 1026706 DRUG

Placebo tablet

Reference Treatment 1: BI 1026706; Reference Treatment 2: Celecoxib; Reference Treatment 3: Pregabalin; Test Treatment 1: BI 1026706; Test Treatment 2: BI 1026706

Pregabalin DRUG

Pregabalin hard capsule

Reference Treatment 3: Pregabalin

BI 1026706 DRUG

BI 1026706 oral solution

Test Treatment 1: BI 1026706; Test Treatment 2: BI 1026706

Celecoxib DRUG

Celecoxib hard capsule

Reference Treatment 2: Celecoxib

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

1320.3.1 Boehringer Ingelheim Investigational Site

Dörnach, Germany

Location

MeSH Terms

Interventions

Pregabalin; Celecoxib

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Benzenesulfonamides; Sulfonamides; Amides; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim pharmaceuticals

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2014
• First Posted: January 15, 2014
• Study Start: January 21, 2014
• Primary Completion: April 9, 2014
• Study Completion: April 15, 2014
• Last Updated: July 5, 2019
• Results First Posted: July 5, 2019

Record last verified: 2019-04

Locations

DE (1)