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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

NCT02037165 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2019-07-05

Study results available
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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

Interventions

DRUG

Placebo to BI 1026706

Placebo tablet

DRUG

Pregabalin

Pregabalin hard capsule

DRUG

BI 1026706

BI 1026706 oral solution

DRUG

Celecoxib

Celecoxib hard capsule

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-01-21
Primary Completion
2014-04-09
Completion
2014-04-15

Countries

  • Germany

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02037165 on ClinicalTrials.gov