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COMPLETED
NCT06429137
PHASE1

A Study in Healthy Men to Test How Well Different Doses of BI 3731579 Are Tolerated

Sponsor: Boehringer Ingelheim

View on ClinicalTrials.gov

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

DRUG

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).

DRUG

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