At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 18 enrolled
Drug / intervention
BI 1015550drug
Likely dose
BI 1015550 18 mgfrom 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.
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)
In Brief
A Phase 1 clinical trial evaluating BI 1015550 for Healthy. Completed, enrolled 18 participants across 1 site.
Detailed Summary
The main objective is to investigate the effect of food on the pharmacokinetics of BI 1015550 Formulation C2.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesGermany
Collaborators--
Timeline
Phase 1CompletedFinished
20252026
First PostedMay 2024
Enrollment StartMay 2024
Primary CompletionJul 2024
TodayJul 2026
First PostedMay 16, 2024
Enrollment StartMay 28, 2024
Primary CompletionJul 24, 2024
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 2.1 years ago
Interventions
BI 1015550drug
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.