A Study in Healthy Men and Women to Test How Well Different Doses of BI 1323495 Are Tolerated
Status:
Completed
Trial end date:
2021-03-26
Target enrollment:
Participant gender:
Summary
The primary objective of this trial is to investigate the safety and tolerability of BI
1323495 in healthy subjects following bid oral administration of multiple rising doses, each
over an 11 day treatment period.
Secondary objectives are the exploration of the pharmacokinetics (PK) including dose
proportionality (only for Part 1) as well as attainment of steady state. This includes
exploration of a therapeutic exposure range, a range not adequately achieved in the
single-rising dose trial 1405-0001.