CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 25 enrolled
Drug / intervention
Placebo to BI 1026706 +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02037165
NCT02037165Phase 1Completed
CompareCT.gov

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 (a Single-blinded, Randomised, Placebo-controlled, Single-dose, Five-way Crossover Study)

Boehringer Ingelheim·interventional·Posted Jan 15, 2014·Updated Jul 5, 2019

In Brief

A Phase 1 clinical trial evaluating Placebo to BI 1026706, Pregabalin, and 2 other interventions for Healthy. Completed, enrolled 25 participants across 1 site.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesGermany
Collaborators--

Timeline

Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJan 15, 2014
Enrollment StartJan 21, 2014
Primary CompletionApr 9, 2014
Study CompletionApr 15, 2014
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 12.5 years ago

Interventions

Placebo to BI 1026706drug

Placebo tablet

Pregabalindrug

Pregabalin hard capsule

BI 1026706drug

BI 1026706 oral solution

Celecoxibdrug

Celecoxib hard capsule