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RECRUITING
NCT06916702
PHASE1

A Study to Test How Well Different Doses of BI 3031185 Are Tolerated by Healthy Men and Women

Sponsor: Boehringer Ingelheim

View on ClinicalTrials.gov

Summary

Part A: The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 3031185 in healthy male subjects following administration of multiple rising doses. Part B: The main objectives of Part B of this trial are to investigate safety, tolerability, and pharmacokinetics (PK) of BI 3031185 in healthy male subjects and female subjects of non-childbearing potential following oral administration of multiple doses of BI 3031185.

Official title: Safety, Tolerability, and Pharmacokinetics of Multiple Rising Oral Doses of BI 3031185 in Healthy Male and Female Subjects (Single-blind, Randomised, Placebo-controlled, Parallel Group Design)

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2025-04-07

Completion Date

2026-10-07

Last Updated

2026-05-22

Healthy Volunteers

Yes

Conditions

Interventions

DRUG

BI 3031185

BI 3031185

DRUG

Midazolam

Midazolam

DRUG

Placebo

Placebo matching BI 3031185

Locations (1)

Charité Research Organisation GmbH

Berlin, Germany