NCT07250048

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Nov 2025

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 18, 2025

Completed
3 days until next milestone

Study Start

First participant enrolled

November 21, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 26, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 2, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 2, 2026

Completed
Last Updated

April 1, 2026

Status Verified

March 1, 2026

Enrollment Period

3 months

First QC Date

November 18, 2025

Last Update Submit

March 27, 2026

Conditions

Healthy

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (16)

SRD part: BI 3009947 Dose group 1

EXPERIMENTAL
Drug: BI 3009947 (Formulation A)

SRD part: BI 3009947 Dose group 2

EXPERIMENTAL
Drug: BI 3009947 (Formulation A)

SRD part: BI 3009947 Dose group 3

EXPERIMENTAL
Drug: BI 3009947 (Formulation A)

SRD part: BI 3009947 Dose group 3fed

EXPERIMENTAL
Drug: BI 3009947 (Formulation A)

SRD part: BI 3009947 Dose group 4

EXPERIMENTAL
Drug: BI 3009947 (Formulation A)

SRD part: BI 3009947 Dose group 4fed

EXPERIMENTAL
Drug: BI 3009947 (Formulation A)

SRD part: BI 3009947 Dose group 5

EXPERIMENTAL
Drug: BI 3009947 (Formulation A)

SRD part: BI 3009947 Dose group 5fed

PLACEBO COMPARATOR
Drug: BI 3009947 (Formulation A)

SRD part: BI 3009947 Dose group 6

EXPERIMENTAL
Drug: BI 3009947 (Formulation A)

SRD part: BI 3009947 Dose group 6fed

EXPERIMENTAL
Drug: BI 3009947 (Formulation A)

SRD part: BI 3009947 Dose group 7

EXPERIMENTAL
Drug: BI 3009947 (Formulation A)

SRD part: BI 3009947 Dose group 7fed

EXPERIMENTAL
Drug: BI 3009947 (Formulation A)

SRD part: Placebo

PLACEBO COMPARATOR
Drug: Placebo

BA part: Treatment sequence R-T1-T2

EXPERIMENTAL

Reference treatment R and test treatments T1 and T2.

Drug: BI 3009947 (Formulation A)Drug: BI 3009947 (Formulation B)

BA part: Treatment sequence T1-R-T2

EXPERIMENTAL

Reference treatment R and test treatments T1 and T2.

Drug: BI 3009947 (Formulation A)Drug: BI 3009947 (Formulation B)

BA part: Treatment sequence T2-R-T1

EXPERIMENTAL

Reference treatment R and test treatments T1 and T2.

Drug: BI 3009947 (Formulation A)Drug: BI 3009947 (Formulation B)

Interventions

PlaceboDRUG

Placebo matching BI 3009947 (Formulation A)

SRD part: Placebo
BI 3009947 (Formulation A)DRUG

BI 3009947 (Formulation A)

BA part: Treatment sequence R-T1-T2BA part: Treatment sequence T1-R-T2BA part: Treatment sequence T2-R-T1SRD part: BI 3009947 Dose group 1SRD part: BI 3009947 Dose group 2SRD part: BI 3009947 Dose group 3SRD part: BI 3009947 Dose group 3fedSRD part: BI 3009947 Dose group 4SRD part: BI 3009947 Dose group 4fedSRD part: BI 3009947 Dose group 5SRD part: BI 3009947 Dose group 5fedSRD part: BI 3009947 Dose group 6SRD part: BI 3009947 Dose group 6fedSRD part: BI 3009947 Dose group 7SRD part: BI 3009947 Dose group 7fed
BI 3009947 (Formulation B)DRUG

BI 3009947 (Formulation B)

BA part: Treatment sequence R-T1-T2BA part: Treatment sequence T1-R-T2BA part: Treatment sequence T2-R-T1

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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
  • Age of 18 to 45 years (inclusive)
  • Body mass index (BMI) of 18.5 to 29.9 kg/m\^2 (inclusive)
  • 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

You may not qualify if:

  • Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
  • 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
  • Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Humanpharmakologisches Zentrum Biberach

Biberach, 88397, Germany

Location

Related Links

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Masking Details
SRD part: participants masked, single blind BA part: no masking, open label
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: SRD part: placebo-controlled BA part: three-way crossover trial with 3 treatment periods to compare the relative bioavailability of reference treatment R and test treatments T1 and T2
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2025

First Posted

November 26, 2025

Study Start

November 21, 2025

Primary Completion

March 2, 2026

Study Completion

March 2, 2026

Last Updated

April 1, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

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

Locations

DE(1)