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CompletedNCT06415045

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

The Effect of Food on the Pharmacokinetics of BI 1015550 (Formulation C2) Following Single Oral Dose Administration in Healthy Subjects (an Open-label, Randomised, Single-dose, Two-period, Two-sequence Crossover Design)

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
18 (actual)
Sponsor
Boehringer Ingelheim · Industry
Sex
All
Age
18 Years – 50 Years
Healthy volunteers
Accepted

Summary

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

Conditions

Interventions

TypeNameDescription
DRUGBI 1015550Participants 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.

Timeline

Start date
2024-05-28
Primary completion
2024-07-24
Completion
2024-07-24
First posted
2024-05-16
Last updated
2025-12-01
Results posted
2025-12-01

Locations

1 site across 1 country: Germany

Source: ClinicalTrials.gov record NCT06415045. Inclusion in this directory is not an endorsement.

A Study in Healthy People to Test How BI 1015550 is Taken up in the Body When Given With or Without Food (NCT06415045) · Clinical Trials Directory