CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 81 enrolled
Drug / intervention
BI 691751 +9 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/NCT01843972
NCT01843972Phase 1Completed

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Rising Oral Doses of BI 691751 in Healthy Male Volunteers in a Randomised, Single-blind, Placebo-controlled Design (Part I) and Investigation of Relative Bioavailability of BI 691751 Given as Tablet and Oral Solution to Healthy Male Subjects in an Open, Randomised, Single-dose, Single Period Parallel Group Design (Part II).

Boehringer Ingelheim·interventional·Posted May 1, 2013·Updated Jun 27, 2016

In Brief

A Phase 1 clinical trial evaluating BI 691751 and Placebo for Healthy. Completed, enrolled 81 participants across 1 site.

Detailed Summary

To investigate safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of single rising doses of BI 691751 in healthy male subjects (part I). To investigate the relative bioavailability of BI 691751 given as tablet versus oral solution (part II)

Study Details

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

Timeline

Phase 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMay 1, 2013
Enrollment StartApr 1, 2013
Primary CompletionNov 1, 2013
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 13.2 years ago

Interventions

BI 691751drug

oral solution BI 691751, dose 6

BI 691751drug

oral solution

Placebodrug

placebo solution

BI 691751drug

oral solution BI 691751, dose 2

BI 691751drug

oral solution BI 691751, dose 5

BI 691751drug

1 tablet

BI 691751drug

oral solution BI 691751, dose 3

BI 691751drug

oral solution BI 69175, dose 4

BI 691751drug

oral solution BI 691751, dose 7

BI 691751drug

oral solution BI 69175, dose 1