NCT07250048

A Study in Healthy Men to Find Out How Different Doses of BI 3009947 Are Tolerated and How Different Formulations or Food Influence How BI 3009947 is Taken up Into the Blood

A Randomised, Single-blind, Placebo-controlled Trial to Investigate Safety, Tolerability, and Pharmacokinetics of Single Rising Doses of BI 3009947 Administered Orally to Healthy Male Trial Participants, and a Randomised, Open-label, Single-dose, Three-way Cross-over Relative Bioavailability Comparison of Two Different Formulations for Oral Administration of BI 3009947 and the Effect of Food on One of These Formulations in Healthy Male Trial Participants

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

Single-rising dose (SRD) part: The main objectives of the SRD part of this trial are to investigate safety, tolerability, and pharmacokinetics (PK) of BI 3009947 in healthy participants following oral administration of single rising doses. Bioavailability (BA) part: The main objective of the BA part is to investigate the relative bioavailability of two different BI 3009947 formulations (Formulation A and B) and to assess the influence of food on the relative bioavailability of Formulation A or B.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	BI 3009947 (Formulation A)	BI 3009947 (Formulation A)
DRUG	BI 3009947 (Formulation B)	BI 3009947 (Formulation B)
DRUG	Placebo	Placebo matching BI 3009947 (Formulation A)

Timeline

• Start date: 2025-11-21
• Primary completion: 2026-03-02
• Completion: 2026-03-02
• First posted: 2025-11-26
• Last updated: 2026-04-01

Locations

1 site across 1 country: Germany