CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 48 enrolled
Drug / intervention
BI 113608 PIB bid +7 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/NCT01681277
NCT01681277Phase 1Completed
CompareCT.gov

Safety, Tolerability and Pharmacokinetics of Multiple Rising Doses of BI 113608 Powder for Oral Solution in Healthy Male Volunteers q.d. or b.i.d. for 14 Days (a Randomised, Double-blind, Placebo-controlled Within Dose Groups Phase I Trial)

Boehringer Ingelheim·interventional·Posted Sep 7, 2012·Updated Jan 20, 2017

In Brief

A Phase 1 clinical trial evaluating BI 113608 PIB bid, Placebo to BI 113608 PIB bid, and 2 other interventions for Healthy. Completed, enrolled 48 participants across 1 site.

Detailed Summary

The objective of the current trial is to evaluate safety, tolerability and pharmacokinetics of multiple rising doses of BI 113608 in healthy male volunteers

Study Details

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

Timeline

Phase 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedSep 7, 2012
Enrollment StartSep 1, 2012
Primary CompletionMay 1, 2013
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 13.8 years ago

Interventions

BI 113608 PIB biddrug

powder for oral solution

Placebo to BI 113608 PIB biddrug

powder for oral solution

Placebo to BI 113608 PIB biddrug

powder for oral solution

Placebo to BI 113608 PIB qddrug

powder for oral solution

Placebo to BI 113608 PIB biddrug

powder for oral solution

BI 113608 PIB biddrug

powder for oral solution

BI 113608 PIB biddrug

powder for oral solution

BI 113608 PIB qddrug

powder for oral solution