NCT04537897

A Study in Healthy Men and Women Who Are Either Between 18 - 45 Years or Between 65 - 80 Years to Test How Different Doses of BI 474121 Are Tolerated

Safety, Tolerability and Pharmacokinetics of Multiple Rising Oral Doses of BI 474121 in Young and Elderly Healthy Male and Female Subjects (Double-blind, Randomised, Placebo-controlled, Parallel Group Design) and Evaluation of Midazolam Interaction in Young Healthy Male and Female Subjects (Nested, Open, Fixed-sequence, Intra-individual Comparison)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

The main objectives of this trial are to investigate safety and tolerability of BI 474121 in healthy male and female young and elderly subjects following oral administration of multiple rising doses per day over 14 days.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	BI 474121	BI474121
DRUG	Midazolam	Midazolam
DRUG	Placebo	Placebo

Timeline

• Start date: 2020-10-06
• Primary completion: 2021-10-07
• Completion: 2021-10-07
• First posted: 2020-09-03
• Last updated: 2024-03-08
• Results posted: 2024-03-08

Locations

1 site across 1 country: Germany