Clinical Trials

NCT IdNCT04107805
TitleA Study in Healthy Men and Women to Test How Well Different Doses of BI 1323495 Are Tolerated
OrganizationBoehringer Ingelheim
Sponsor/CollaboratorsBoehringer Ingelheim
Older Adult
Location (with distance)
  • Fraunhofer ITEM, Hannover, 30625 , Germany
DescriptionThe 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.