NCT04801693

A Study in Healthy Men to Test How Well Different Doses of BI 1819479 Are Tolerated and Taken up by the Body With or Without Food

Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 1819479 in Healthy Male Subjects (Single-blind, Randomised, Placebo-controlled Parallel Group Design) and Effect of Food on the Relative Bioavailability of BI 1819479 (Open-label, Randomised, Two-way Crossover Design)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The main objectives of the single rising doses (SRD) trial part are to investigate safety, tolerability and pharmacokinetics (PK) of BI 1819479 in healthy male subjects following administration of single rising doses. The main objective of the food effect part is to investigate the influence of food on the relative bioavailability of BI 1819479.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	BI 1819479	BI 1819479
DRUG	Placebo	Placebo

Timeline

• Start date: 2021-05-26
• Primary completion: 2022-04-25
• Completion: 2022-04-25
• First posted: 2021-03-17
• Last updated: 2022-05-04

Locations

1 site across 1 country: Germany