NCT03802331

A Study to Test How Food Influences the Amount of BI 1323495 in the Blood of Healthy Men

Relative Bioavailability of BI 1323495 Following Oral Administration Under Fed and Fasted Conditions in Healthy Male Subjects (an Open-label, Randomised, Single-dose, Two-period, Two-sequence Crossover Study)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The main objective of this trial is to assess the effect of food on the pharmacokinetics of an oral tablet formulation of BI 1323495 by investigating the relative bioavailability following single dose administration under fed and fasted conditions.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	BI 1323495,	single oral doses

Timeline

• Start date: 2019-01-28
• Primary completion: 2019-03-03
• Completion: 2019-03-03
• First posted: 2019-01-14
• Last updated: 2024-02-22
• Results posted: 2024-02-22

Locations

1 site across 1 country: Germany