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A Study in Healthy People to Test How BI 1015550 is Taken up in the Body When Given With or Without Food

NCT06415045 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2025-12-01

Study results available
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Summary

The main objective is to investigate the effect of food on the pharmacokinetics of BI 1015550 Formulation C2.

Conditions

  • Healthy

Interventions

DRUG

BI 1015550

Participants received a single 18 mg Nerandomilast Formulation C2 film-coated tablet either after an overnight fast of at least 10 hours or following a high-fat, high-calorie meal.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2024-05-28
Primary Completion
2024-07-24
Completion
2024-07-24

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 NCT06415045 on ClinicalTrials.gov