CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 24 enrolled
Drug / intervention
Reference (R) +2 moredrug
Likely dose
Reference (R) 6 milligramfrom 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/NCT05428436
NCT05428436Phase 1Completed
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Relative Bioavailability Comparison of BI 1015550 as the Intended Commercial Formulation (iCF) Versus Trial Formulation 2 and iCF With and Without Food Following Oral Administration in Healthy Subjects (an Open-label, Randomised, Single-dose, Three-way Crossover Trial)

Boehringer Ingelheim·interventional·Posted Jun 23, 2022·Updated Dec 19, 2025

In Brief

A Phase 1 clinical trial evaluating Reference (R), Test treatment 1 (T1), and 1 other intervention for Healthy. Completed, enrolled 24 participants across 1 site.

Detailed Summary

The main objective of this trial is to investigate the relative bioavailability of BI 1015550 intended Commercial Formulation (iCF) compared with Trial Formulation 2 (TF2) and the effect of food on the pharmacokinetics of BI 1015550 iCF following oral administration.

Study Details

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

Timeline

Phase 1CompletedFinished
2023202420252026
First PostedJun 23, 2022
Enrollment StartAug 15, 2022
Primary CompletionSep 30, 2022
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 4.0 years ago

Interventions

Reference (R)drug

Reference (R): three 6 milligram BI 1015550 film-coated tablets of Trial Formulation 2 (TF2) taken orally following an overnight fast of at least 10 hours.

Test treatment 1 (T1)drug

Test treatment 1 (T1): one 18 milligram BI 1015550 film-coated tablet of the intended commercial formulation (iCF) taken orally following an overnight fast of at least 10 hours.

Test treatment 2 (T2)drug

Test treatment 2 (T2): one 18 milligram BI 1015550 film-coated tablet of the intended commercial formulation (iCF) taken orally following a high-calorie breakfast.