NCT06624072

A Study in Healthy People to Compare 2 Different Formulations of Nerandomilast Tablets When Taken With or Without Food

Relative Bioavailability of Two Different Formulations of Nerandomilast and Investigation of the Food Effect on New Formulation Following Oral Administration in Healthy Adult Male and Female Subjects (an Open-label, Randomised, Single-dose, Three-way Crossover Trial)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The main objective of this trial is to investigate two different formulations of nerandomilast and the effect of food on the pharmacokinetics of the new formulation following oral administration.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Nerandomilast 18 mg - adult formulation	BI 1015550, oral tablet
DRUG	Nerandomilast 1 mg - paediatric formulation	BI 1015550, oral tablet

Timeline

• Start date: 2024-10-15
• Primary completion: 2024-11-22
• Completion: 2024-11-30
• First posted: 2024-10-02
• Last updated: 2026-01-08
• Results posted: 2026-01-08

Locations

1 site across 1 country: Germany