A Study to Test How Different Doses of BI 3731579 Are Tolerated by Healthy People

Phase 1

Terminated

• Conditions: Healthy
• Interventions: Drug: BI 3731579; Drug: Placebo matching BI 3731579; Drug: Midazolam

• Registration Number: NCT06716190
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics and pharmacodynamics of BI 3731579 in healthy volunteers following administration of multiple rising doses per day over 15 days.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-11-29
• Study First Submitted QC: 2024-11-29
• Study First Posted: 2024-12-04
• Study Start: 2024-12-18
• Primary Completion: 2025-06-05
• Study Completion: 2025-06-05
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-14
• Last Update Posted: 2025-07-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MRD: BI 3731579 dose group 1	BI 3731579	MRD= Multiple rising doses
MRD: BI 3731579 dose group 1	Midazolam	MRD= Multiple rising doses
MRD: BI 3731579 dose group 2	BI 3731579	-
MRD: BI 3731579 dose group 2	Midazolam	-
MRD: BI 3731579 dose group 3	BI 3731579	-
MRD: BI 3731579 dose group 3	Midazolam	-
MRD: BI 3731579 dose group 4	BI 3731579	-
MRD: BI 3731579 dose group 4	Midazolam	-
MRD: Placebo matching BI 3731579	Placebo matching BI 3731579	-
MRD: Placebo matching BI 3731579	Midazolam	-

Primary Outcome Measures

Name	Time	Method
Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator	up to Day 27.

Secondary Outcome Measures

Name	Time	Method
AUCτ,ss (area under the concentration-time curve of BI 3731579 in plasma at steady state over a uniform dosing interval τ)	up to Day 19.
Cmax,ss (maximum measured concentration of BI 3731579 in plasma at steady state over a uniform dosing interval τ)	up to Day 19.

Trial Locations

Locations (1)

SGS Life Science Services - Clinical Research; 🇧🇪 Edegem, Belgium