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A Study in Healthy Men to Test How Well Different Doses of BI 3731579 Are Tolerated
Sponsor: Boehringer Ingelheim
Summary
The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 3731579 in healthy male subjects.
Official title: A Partially Randomised, Single-blind, Placebo-controlled Trial to Investigate Safety, Tolerability, and Pharmacokinetics of Single Rising Doses of BI 3731579 Administered as Tablet to Healthy Male Subjects
Key Details
Gender
MALE
Age Range
18 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
63
Start Date
2024-07-08
Completion Date
2025-05-27
Last Updated
2026-08-10
Healthy Volunteers
Yes
Conditions
Interventions
BI 3731579
Participants received a single oral dose of BI 3731579 as film-coated tablets, with 240 mL of water following an overnight fast of at least 10 hrs. The doses received were respectively 6 mg (DG 1), 21 mg (DG 2), 60 mg (DG 3), 120 mg (DG 4), 210 mg (DG 5), 360 mg (DG 6), 480 mg (DG 7) and 600 mg (DG 8).
Placebo
Participants received BI 3731579-matched placebo as film-coated tablets and as a single oral dose, with 240 milliliters (mL) of water following an overnight fast of at least 10 hours (hrs).
Locations (1)
Humanpharmakologisches Zentrum Biberach
Biberach, Germany