NCT03794323

A Study in Healthy Men to Find Out How Well Different Doses of BI 764122 Are Tolerated and Whether Food Affects the Amount of BI 764122 in the Blood

Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 764122 (Single-blind, Partially Randomised, Placebo-controlled, Parallel (Sequential) Group Design) and the Effect of Food on BI 764122 (Open-label, Randomised, Single-dose, Two-period, Two-sequence Crossover Design) in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 764122 in healthy male subjects following oral administration of single rising doses. The objective of the food effect (FE) part is to investigate the relative bioavailability of BI 764122 under fed and fasted conditions.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	BI 764122	Tablet
DRUG	Placebo	Tablet

Timeline

• Start date: 2019-01-30
• Primary completion: 2019-08-12
• Completion: 2019-08-12
• First posted: 2019-01-07
• Last updated: 2023-05-01
• Results posted: 2023-05-01

Locations

1 site across 1 country: Belgium