Participant Flow Module
The Participant Flow Module provides information about the flow of participants through each stage of the clinical trial. This includes pre-assignment details, recruitment information, and the types of units analyzed, helping researchers understand how participants move through the study.
Participant Flow Module path is as follows:
Study -> Results Section -> Participant Flow Module
Participant Flow Module
Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-25 @ 9:53 PM
NCT ID:
NCT04619251
Pre Assignment Details:
All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated. Administrations of BI 1323495 was separated by a wash-out phase of at least 11 days.
Recruitment Details:
This was a two part clinical trial, the first part was single rising dose (SRD) and multiple dose (MD), the second part evaluates drug-drug interaction (DDI) with itraconazole. The study was performed in healthy Japanese men genotyped as poor metabolizers (PM) or as extensive metabolizers (EM) to test how different doses of BI 1323495 are tolerated and how itraconazole influences the amount of BI 1323495 in the blood.
Study:
NCT04619251
Study Brief:
Results Section:
NCT04619251