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

Boehringer Ingelheim

Status and phase: Enrolling; Phase 1

Conditions: Healthy

Treatments: Drug: BI 3009947 (Formulation A); Drug: BI 3009947 (Formulation B); Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07250048

1533-0001

2025-521095-66-00 (Registry Identifier)

U1111-1318-3257 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 68 estimated patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

68 participants in 16 patient groups, including a placebo group

SRD part: BI 3009947 Dose group 1

Experimental group

Treatment:

Drug: BI 3009947 (Formulation A)

SRD part: BI 3009947 Dose group 2

Experimental group

Treatment:

Drug: BI 3009947 (Formulation A)

SRD part: BI 3009947 Dose group 3

Experimental group

Treatment:

Drug: BI 3009947 (Formulation A)

SRD part: BI 3009947 Dose group 3fed

Experimental group

Treatment:

Drug: BI 3009947 (Formulation A)

SRD part: BI 3009947 Dose group 4

Experimental group

Treatment:

Drug: BI 3009947 (Formulation A)

SRD part: BI 3009947 Dose group 4fed

Experimental group

Treatment:

Drug: BI 3009947 (Formulation A)

SRD part: BI 3009947 Dose group 5

Experimental group

Treatment:

Drug: BI 3009947 (Formulation A)

SRD part: BI 3009947 Dose group 5fed

Placebo Comparator group

Treatment:

Drug: BI 3009947 (Formulation A)

SRD part: BI 3009947 Dose group 6

Experimental group

Treatment:

Drug: BI 3009947 (Formulation A)

SRD part: BI 3009947 Dose group 6fed

Experimental group

Treatment:

Drug: BI 3009947 (Formulation A)

SRD part: BI 3009947 Dose group 7

Experimental group

Treatment:

Drug: BI 3009947 (Formulation A)

SRD part: BI 3009947 Dose group 7fed

Experimental group

Treatment:

Drug: BI 3009947 (Formulation A)

SRD part: Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

BA part: Treatment sequence R-T1-T2

Experimental group

Description:

Reference treatment R and test treatments T1 and T2.

Treatment:

Drug: BI 3009947 (Formulation B)

Drug: BI 3009947 (Formulation A)

BA part: Treatment sequence T1-R-T2

Experimental group

Description:

Reference treatment R and test treatments T1 and T2.

Treatment:

Drug: BI 3009947 (Formulation B)

Drug: BI 3009947 (Formulation A)

BA part: Treatment sequence T2-R-T1

Experimental group

Description:

Reference treatment R and test treatments T1 and T2.

Treatment:

Drug: BI 3009947 (Formulation B)

Drug: BI 3009947 (Formulation A)