NCT04194645

A Study in Healthy Men to Test How the Body Takes up and Tolerates Different Doses of BI 474121, and Whether it Makes a Difference if BI 474121 is Taken as a Tablet or a Drink.

A Randomised, Single-blind, Placebo-controlled Trial to Investigate Safety, Tolerability, and Pharmacokinetics of Single Rising Oral Doses of BI 474121 Administered as Oral Solution and Tablets to Healthy Male Subjects (SRD Part), and a Randomised, Open-label, Single-dose, Three-way Cross-over Bioavailability Comparison of BI 474121 as Tablet Versus Oral Solution and Tablet With and Without Food (BA Part)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 474121 in healthy male subjects following oral administration of single rising doses.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	BI 474121 tablet	BI 474121 tablet
DRUG	Placebo tablet	Placebo tablet
DRUG	BI 474121 oral solution	BI 474121 oral solution
DRUG	Placebo solution	Placebo solution

Timeline

• Start date: 2020-01-09
• Primary completion: 2021-03-25
• Completion: 2021-03-25
• First posted: 2019-12-11
• Last updated: 2024-03-26
• Results posted: 2024-03-26

Locations

1 site across 1 country: Germany