At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 12 enrolled
Drug / intervention
Nerandomilastdrug
Likely dose
Not stated in 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.
Pharmacokinetics of R-BI 1015550 After Single Oral Doses of BI 1015550 in Japanese Healthy Male Subjects (Open-label, Non-randomised, and Parallel Group Design)
In Brief
A Phase 1 clinical trial evaluating Nerandomilast for Healthy. Completed, enrolled 12 participants across 1 site.
Detailed Summary
The main objectives of this trial are to investigate pharmacokinetics (PK) of R-BI 1015550 in Japanese healthy male subjects following oral administration of two different single BI 1015550 doses.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesJapan
Collaborators--
Timeline
Phase 1CompletedFinished
202420252026
First PostedNov 2023
Enrollment StartDec 2023
Primary CompletionFeb 2024
Study CompletionFeb 2024
TodayJul 2026
First PostedNov 18, 2023
Enrollment StartDec 20, 2023
Primary CompletionFeb 7, 2024
Study CompletionFeb 13, 2024
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 2.6 years ago
Interventions
Nerandomilastdrug
Participants were administered a single film-coated tablet of nerandomilast (Formulation C1), orally with 240 milliliters (mL) of water after an overnight fast of at least 10 hours (h).