At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 24 enrolled
Drug / intervention
BI 1358894, intended Commercial Formulation (iCF) (T) +1 moredrug
Likely dose
BI 1358894, intended Commercial Formulation (iCF) (T) 100 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.
Relative Bioavailability of Two Different Tablet Formulations of BI 1358894 Administered in Healthy Subjects in Fasted and Fed State (an Open-label, Randomised, Single-dose, Four-period, Four-sequence Crossover Study)
In Brief
A Phase 1 clinical trial evaluating BI 1358894, intended Commercial Formulation (iCF) (T) and BI 1358894, Trial Formulation 2 (TFII) (R) for Healthy. Completed, enrolled 24 participants across 1 site.
Detailed Summary
To investigate the relative bioavailability of the intended Commercial Formulation (iCF) (Test, T) compared with Trial Formulation 2 (TFII) (Reference, R) and to assess potential food effects following oral administration of BI 1358894.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesGermany
Collaborators--
Timeline
Phase 1CompletedFinished
20222023202420252026
First PostedDec 2021
Enrollment StartJan 2022
Primary CompletionMay 2022
TodayJul 2026
First PostedDec 13, 2021
Enrollment StartJan 14, 2022
Primary CompletionMay 16, 2022
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 4.6 years ago
Interventions
BI 1358894, intended Commercial Formulation (iCF) (T)drug
A single dose of 100 mg (milligram) BI 1358894 given orally as a film-coated tablet in the morning
BI 1358894, Trial Formulation 2 (TFII) (R)drug
A single dose of 100 mg (milligram) BI 1358894 given orally as a film-coated tablet in the morning.