At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 15 enrolled
Drug / intervention
Nerandomilast 18 mg - adult formulation +1 moredrug
Likely dose
Nerandomilast 18 mg - adult formulationfrom 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.
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)
In Brief
A Phase 1 clinical trial evaluating Nerandomilast 18 mg - adult formulation and Nerandomilast 1 mg - paediatric formulation for Healthy. Completed, enrolled 15 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesGermany
Collaborators--
Timeline
Phase 1CompletedFinished
20252026
First PostedOct 2024
Enrollment StartOct 2024
Primary CompletionNov 2024
Study CompletionNov 2024
TodayJul 2026
First PostedOct 2, 2024
Enrollment StartOct 15, 2024
Primary CompletionNov 22, 2024
Study CompletionNov 30, 2024
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 1.8 years ago
Interventions
Nerandomilast 18 mg - adult formulationdrug
BI 1015550, oral tablet
Nerandomilast 1 mg - paediatric formulationdrug
BI 1015550, oral tablet