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

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.

Study Overview

• Status: Terminated
• Conditions: Healthy
• Intervention / Treatment: Drug: BI 3009947 (Formulation A); Drug: Placebo; Drug: BI 3009947 (Formulation B)

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Biberach, Germany, 88397
    • Humanpharmakologisches Zentrum Biberach

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Healthy male trial participant according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
2. Age of 18 to 45 years (inclusive)
3. Body mass index (BMI) of 18.5 to 29.9 kg/m^2 (inclusive)
4. Signed and dated written informed consent in accordance with international council for harmonisation-good clinical practice (ICH-GCP) and local legislation prior to admission to the trial

Exclusion Criteria:

1. Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
2. Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 bpm
3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
4. Any evidence of a concomitant disease. This does not include acceptable concomitant conditions that were not assessed as clinically relevant by the investigator (e.g. possible cases of myopia, hyperopia, astigmatism, non-active pollinosis, or mild acne of the skin)
5. Further exclusion criteria apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

16

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: SRD part: Placebo	Drug: Placebo; Placebo matching BI 3009947 (Formulation A)
Experimental: SRD part: BI 3009947 Dose group 1	Drug: BI 3009947 (Formulation A); BI 3009947 (Formulation A)
Experimental: SRD part: BI 3009947 Dose group 2	Drug: BI 3009947 (Formulation A); BI 3009947 (Formulation A)
Experimental: SRD part: BI 3009947 Dose group 3	Drug: BI 3009947 (Formulation A); BI 3009947 (Formulation A)
Experimental: SRD part: BI 3009947 Dose group 4	Drug: BI 3009947 (Formulation A); BI 3009947 (Formulation A)
Experimental: SRD part: BI 3009947 Dose group 5	Drug: BI 3009947 (Formulation A); BI 3009947 (Formulation A)
Experimental: SRD part: BI 3009947 Dose group 6	Drug: BI 3009947 (Formulation A); BI 3009947 (Formulation A)
Experimental: SRD part: BI 3009947 Dose group 7	Drug: BI 3009947 (Formulation A); BI 3009947 (Formulation A)
Experimental: BA part: Treatment sequence R-T1-T2; Reference treatment R and test treatments T1 and T2.	Drug: BI 3009947 (Formulation A); BI 3009947 (Formulation A); Drug: BI 3009947 (Formulation B); BI 3009947 (Formulation B)
Experimental: BA part: Treatment sequence T1-R-T2; Reference treatment R and test treatments T1 and T2.	Drug: BI 3009947 (Formulation A); BI 3009947 (Formulation A); Drug: BI 3009947 (Formulation B); BI 3009947 (Formulation B)
Experimental: BA part: Treatment sequence T2-R-T1; Reference treatment R and test treatments T1 and T2.	Drug: BI 3009947 (Formulation A); BI 3009947 (Formulation A); Drug: BI 3009947 (Formulation B); BI 3009947 (Formulation B)
Experimental: SRD part: BI 3009947 Dose group 3fed	Drug: BI 3009947 (Formulation A); BI 3009947 (Formulation A)
Experimental: SRD part: BI 3009947 Dose group 4fed	Drug: BI 3009947 (Formulation A); BI 3009947 (Formulation A)
Placebo Comparator: SRD part: BI 3009947 Dose group 5fed	Drug: BI 3009947 (Formulation A); BI 3009947 (Formulation A)
Experimental: SRD part: BI 3009947 Dose group 6fed	Drug: BI 3009947 (Formulation A); BI 3009947 (Formulation A)
Experimental: SRD part: BI 3009947 Dose group 7fed	Drug: BI 3009947 (Formulation A); BI 3009947 (Formulation A)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SRD part: Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator	This is expressed as the percentage of subjects treated with investigational drug who experience such an event.	up to Day 14
BA part: AUC0-24 (area under the concentration-time curve of BI 3009947 in plasma over the dosing interval 0 to 24 hours)		up to Day 3
BA part: AUC0-24 (area under the concentration-time curve of the metabolite BI 3037996 in plasma over the dosing interval 0 to 24 hours)		up to Day 3
BA part: Cmax (maximum measured concentration of BI 3009947 in plasma)		up to Day 3
BA part: Cmax (maximum measured concentration of the metabolite BI 3037996 in plasma)		up to Day 3

Secondary Outcome Measures

Outcome Measure	Time Frame
SRD part: AUC0-24 (area under the concentration-time curve of BI 3009947 in plasma over the dosing interval 0 to 24 hours)	up to Day 3
SRD part: AUC0-24 (area under the concentration-time curve of the metabolite BI 3037996 in plasma over the dosing interval 0 to 24 hours)	up to Day 3
SRD part: Cmax (maximum measured concentration of BI 3009947 in plasma)	up to Day 3
SRD part: Cmax (maximum measured concentration of the metabolite BI 3037996 in plasma)	up to Day 3
BA part: AUC0-∞ (area under the concentration-time curve of BI 3009947 in plasma over the time interval from 0 extrapolated to infinity)	up to Day 3
BA part: AUC0-∞ (area under the concentration-time curve of the metabolite BI 3037996 in plasma over the time interval from 0 extrapolated to infinity)	up to Day 3

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2025
• Primary Completion (Actual): March 2, 2026
• Study Completion (Actual): March 2, 2026

Study Registration Dates

• First Submitted: November 18, 2025
• First Submitted That Met QC Criteria: November 18, 2025
• First Posted (Actual): November 26, 2025

Study Record Updates

• Last Update Posted (Actual): April 1, 2026
• Last Update Submitted That Met QC Criteria: March 27, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 1533-0001; 2025-521095-66-00 (Registry Identifier: CTIS); U1111-1318-3257 (Registry Identifier: WHO - International Clinical Trials Registry Platform (ICTRP))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).

For more details refer to:

https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No