At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 14 enrolled
Drug / intervention
BI 1015550 +2 moredrug
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.
The Effect of Multiple Oral Doses of BI 1015550 on the Pharmacokinetics of Nintedanib and Pirfenidone Administered Single Dose to Healthy Male Subjects (Open-label, Two-period, Fixed-sequence Crossover Trial)
In Brief
A Phase 1 clinical trial evaluating BI 1015550, Nintedanib, and 1 other intervention for Healthy. Completed, enrolled 14 participants across 1 site.
Detailed Summary
The main objective of this trial is to investigate the induction effect of multiple oral doses of BI 1015550 on the pharmacokinetics of nintedanib or pirfenidone.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesGermany
Collaborators--
Timeline
Phase 1CompletedFinished
202420252026
First PostedOct 2023
Enrollment StartNov 2023
Primary CompletionDec 2023
TodayJul 2026
First PostedOct 6, 2023
Enrollment StartNov 8, 2023
Primary CompletionDec 14, 2023
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 2.7 years ago
Interventions
BI 1015550drug
BI 1015550
Nintedanibdrug
Soft capsules
Pirfenidonedrug
Film-coated tablets