CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 76 enrolled
Drug / intervention
BI 764122 +1 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/NCT03794323
NCT03794323Phase 1Completed
CompareCT.gov

Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 764122 (Single-blind, Partially Randomised, Placebo-controlled, Parallel (Sequential) Group Design) and the Effect of Food on BI 764122 (Open-label, Randomised, Single-dose, Two-period, Two-sequence Crossover Design) in Healthy Male Subjects

Boehringer Ingelheim·interventional·Posted Jan 7, 2019·Updated May 1, 2023

In Brief

A Phase 1 clinical trial evaluating BI 764122 and Placebo for Healthy. Completed, enrolled 76 participants across 1 site.

Detailed Summary

The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 764122 in healthy male subjects following oral administration of single rising doses. The objective of the food effect (FE) part is to investigate the relative bioavailability of BI 764122 under fed and fasted conditions.

Study Details

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

Timeline

Phase 1CompletedFinished
20192020202120222023202420252026
First PostedJan 7, 2019
Enrollment StartJan 30, 2019
Primary CompletionAug 12, 2019
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 7.5 years ago

Interventions

BI 764122drug

Tablet

Placebodrug

Tablet