NCT04107805

A Study in Healthy Men and Women to Test How Well Different Doses of BI 1323495 Are Tolerated

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Rising Oral Doses of BI 1323495 Versus Placebo in Healthy Subjects, Including an Investigation of Drug-drug Interaction With Microdose Midazolam (Double-blind, Randomised, Placebo-controlled [Within Dose Groups] Trial)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 87 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

The primary objective of this trial is to investigate the safety and tolerability of BI 1323495 in healthy subjects following bid oral administration of multiple rising doses, each over an 11 day treatment period. Secondary objectives are the exploration of the pharmacokinetics (PK) including dose proportionality (only for Part 1) as well as attainment of steady state. This includes exploration of a therapeutic exposure range, a range not adequately achieved in the single-rising dose trial 1405-0001.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	BI 1323495	Tablet
DRUG	Placebo	Tablet
DRUG	Midazolam	Oral administration

Timeline

• Start date: 2019-11-04
• Primary completion: 2021-03-05
• Completion: 2021-03-26
• First posted: 2019-09-27
• Last updated: 2024-02-22
• Results posted: 2024-02-22

Locations

1 site across 1 country: Germany