NCT06791187

Brief Summary

The main objective of this trial is to investigate the effect of a single dose of BI 1291583 on the pharmacokinetics of a single dose of dabigatran, an efflux transporter P-glycoprotein (P-gp) substrate.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Jan 2025

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

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

January 20, 2025

Completed
3 days until next milestone

Study Start

First participant enrolled

January 23, 2025

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 24, 2025

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 21, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 27, 2025

Completed
Last Updated

August 13, 2025

Status Verified

August 1, 2025

Enrollment Period

29 days

First QC Date

January 20, 2025

Last Update Submit

August 8, 2025

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • Area under the concentration-time curve of dabigatran in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)

    Up to 4 days

  • Maximum measured concentration of dabigatran in plasma (Cmax)

    Up to 4 days

Secondary Outcomes (1)

  • Area under the concentration-time curve of dabigatran in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)

    Up to 4 days

Study Arms (1)

dabigatran alone (R) followed by dabigatran + BI 1291583 combination (T)

EXPERIMENTAL

R=reference treatment (period 1) T=test treatment (period 2)

Drug: dabigatran etexilateDrug: BI 1291583

Interventions

dabigatran etexilateDRUG

dabigatran etexilate

Also known as: Pradaxa
dabigatran alone (R) followed by dabigatran + BI 1291583 combination (T)
BI 1291583DRUG

BI 1291583

Also known as: Verducatib
dabigatran alone (R) followed by dabigatran + BI 1291583 combination (T)

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Subjects will only be included in the trial if they meet the following criteria:
  • Healthy male subjects 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 55 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 ICH-GCP and local legislation prior to admission to the trial

You may not qualify if:

  • Subjects will not be allowed to participate, if any of the following general criteria apply:
  • Any finding in the medical examination (including Blood pressure (BP) Pulse rate (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 45 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 assessed as clinically relevant by the investigator
  • Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
  • Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
  • Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Humanpharmakologisches Zentrum Biberach

Biberach, 88397, Germany

Location

Related Links

MeSH Terms

Interventions

Dabigatran

Intervention Hierarchy (Ancestors)

PyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Participants cross over from test treatment (T) to reference treatment (R) (two periods, fixed sequence).
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2025

First Posted

January 24, 2025

Study Start

January 23, 2025

Primary Completion

February 21, 2025

Study Completion

March 27, 2025

Last Updated

August 13, 2025

Record last verified: 2025-08

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.mystudywindow.com/msw/datatransparency

Locations

DE(1)