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A Study in Healthy People to Compare 2 Different Formulations of BI 1015550 Taken With or Without Food

NCT05428436 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-12-19

Study results available
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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.

Conditions

  • Healthy

Interventions

DRUG

Reference (R)

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.

DRUG

Test treatment 1 (T1)

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.

DRUG

Test treatment 2 (T2)

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.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-08-15
Primary Completion
2022-09-30
Completion
2022-09-30

Countries

  • Germany

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05428436 on ClinicalTrials.gov