CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 18 enrolled
Drug / intervention
iCF1(T1) 25 milligram BI 425809 +2 moredrug
Likely dose
iCF1(T1) 25 milligram BI 425809from 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.

Search/NCT03817476
NCT03817476Phase 1Completed
CompareCT.gov

Relative Bioavailability of Batch 1 and Batch 2 of the Intended Commercial Formulation of BI 425809 Compared to Each Other and to TF 2 Formulation of BI 425809 Following Oral Administration in Healthy Male and Female Subjects (Randomized, Open-label, Single-dose, Three-treatment, Three-period, Six-sequence Crossover Study)

Boehringer Ingelheim·interventional·Posted Jan 25, 2019·Updated Apr 24, 2026

In Brief

A Phase 1 clinical trial evaluating iCF1(T1) 25 milligram BI 425809, iCF2(T2) 25 milligram BI 425809, and 1 other intervention for Healthy. Completed, enrolled 18 participants across 1 site.

Detailed Summary

The main objective of this trial is to investigate the relative bioavailability of batch 1 of the intended commercial tablet formulation (iCF1) of BI 425809 vs batch 2 of the intended commercial tablet formulation (iCF2) of BI 425809 vs BI 425809 (TF2) formulation.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesGermany
Collaborators--

Timeline

Phase 1CompletedFinished
20192020202120222023202420252026
First PostedJan 25, 2019
Enrollment StartFeb 11, 2019
Primary CompletionMay 28, 2019
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 7.4 years ago

Interventions

iCF1(T1) 25 milligram BI 425809drug

One 25 milligram BI 425809 iCF1 tablet. Oral with 240 milliliter of water after an overnight fast of at least 10 hours.

iCF2(T2) 25 milligram BI 425809drug

One 25 milligram BI 425809 iCF2 tablet. Oral with 240 milliliter of water after an overnight fast of at least 10 hours.

TF2(R) 25 milligram BI 425809drug

One 25 milligram BI 425809 TF2 tablet. Oral with 240 milliliter of water after an overnight fast of at least 10 hours.