CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 70 enrolled
Drug / intervention
BI 1015550 +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/NCT01594515
NCT01594515Phase 1Completed

Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 1015550 in Healthy Male Volunteers (a Partially Randomised, Partially Single-blind, Placebo-controlled Phase I Study)

Boehringer Ingelheim·interventional·Posted May 9, 2012·Updated Dec 15, 2015

In Brief

A Phase 1 clinical trial evaluating BI 1015550, Placebo, and 1 other intervention for Healthy. Completed, enrolled 70 participants across 1 site.

Detailed Summary

In this first-in-man trial, safety, tolerability, pharmacokinetics, and selected pharmacodynamics parameters of BI 1015550 will be assessed in healthy male volunteers.

Study Details

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

Timeline

Phase 1CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMay 9, 2012
Enrollment StartMay 1, 2012
Primary CompletionSep 1, 2012
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 14.1 years ago

Interventions

BI 1015550drug

High dose powder for oral solution

BI 1015550drug

Medium dose powder for oral solution

BI 1015550drug

Low dose powder for oral solution

BI 1015550drug

Low dose powder for oral solution

BI 1015550drug

Low dose powder for oral solution

Placebodrug

Solution for oral administration

BI 101550drug

High dose powder for oral solution

BI 1015550drug

Low dose powder for oral solution

BI 1015550drug

Medium dose powder for oral solution

BI 1015550drug

Medium dose powder for oral solution