NCT05520827

A Study in Healthy Men to Test How Different Doses of BI 1584862 Are Tolerated and How BI 1584862 is Taken up in the Body With or Without Food

A Randomised, Single-blind, Placebo-controlled Trial to Investigate Safety, Tolerability, and Pharmacokinetics of Single Rising Doses of BI 1584862 Administered as Tablet to Healthy Male Subjects (SRD Part), and a Randomised, Open-label, Single-dose, Two-way Crossover Part Investigating Relative Bioavailability of BI 1584862 as Tablet With and Without Food in Healthy Male Subjects (FE Part)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 77 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

Single Rising Dose (SRD) part: The main objectives of the SRD part of this trial are to investigate safety, tolerability, and pharmacokinetics (PK) of BI 1584862 in healthy male subjects following oral administration of single rising doses. Food Effect (FE) part: The main objective of the FE part is to assess the influence of food on the relative bioavailability of the BI 1584862 tablet.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	BI 1584862	BI 1584862
DRUG	Placebo	Placebo

Timeline

• Start date: 2022-09-29
• Primary completion: 2023-03-06
• Completion: 2023-03-06
• First posted: 2022-08-30
• Last updated: 2023-03-09

Locations

1 site across 1 country: Germany