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A Study to Test How Well Different Doses of BI 3031185 Are Tolerated by Healthy Men and Women
Sponsor: Boehringer Ingelheim
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
BI 3031185
BI 3031185
Midazolam
Midazolam
Placebo
Placebo matching BI 3031185
Locations (1)
Charité Research Organisation GmbH
Berlin, Germany