CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 80 enrolled
Drug / intervention
BI 113608 +10 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/NCT01540825
NCT01540825Phase 1Completed
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Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 113608 in Healthy Male Volunteers (Randomised, Double-blind, Placebo-controlled Within Dose Groups)

Boehringer Ingelheim·interventional·Posted Feb 29, 2012·Updated Jan 20, 2017

In Brief

A Phase 1 clinical trial evaluating BI 113608 and Placebo for Healthy. Completed, enrolled 80 participants across 1 site.

Detailed Summary

The primary objective of the current study is to investigate the safety and tolerability of BI 113608 in healthy male volunteers following oral administration of single rising doses. A secondary objective is the exploration of the pharmacokinetics of BI 113608 after single dosing.

Study Details

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

Timeline

Phase 1CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedFeb 29, 2012
Enrollment StartFeb 1, 2012
Primary CompletionMay 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 14.3 years ago

Interventions

BI 113608drug

Low dose powder for oral solution

BI 113608drug

High dose powder for oral solution

BI 113608drug

Medium dose powder for oral solution

BI 113608drug

Low dose powder for oral solution

Placebodrug

Powder for oral solution

BI 113608drug

Low dose powder for oral solution

BI 113608drug

High dose powder for oral solution

BI 113608drug

High dose powder for oral solution

BI 113608drug

Medium dose powder for oral solution

BI 113608drug

Medium dose powder for oral solution

BI 113608drug

Low dose powder for oral solution