Clinical trial NCT06791187: A Study in Healthy People to Test Whether BI 1291583 Influences the Amount of Dabigatran in the Body
Official title: The Effect of a Single Dose of BI 1291583 on the Pharmacokinetics of a Single Dose of Dabigatran Following Oral Administration in Healthy Adult Male Subjects (an Open-label, 2- Period, Fixed-sequence Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2025-01-24
Enrollment: 14
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: CROSSOVER
Intervention model description: Participants cross over from test treatment (T) to reference treatment (R) (two periods, fixed sequence).
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria :

Subjects will only be included in the trial if they meet the following criteria:

1. 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
2. Age of 18 to 55 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 ICH-GCP and local legislation prior to admission to the trial

Exclusion Criteria :

Subjects will not be allowed to participate, if any of the following general criteria apply:

1. 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
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 45 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 assessed as clinically relevant by the investigator
5. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
6. Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
7. Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
8. History of relevant orthostatic hypotension, fainting spells, or blackouts Further exclusion criteria apply.

Primary outcomes:
measure: Area under the concentration-time curve of dabigatran in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)
timeFrame: Up to 4 days
measure: Maximum measured concentration of dabigatran in plasma (Cmax)
timeFrame: Up to 4 days
Secondary outcomes:
measure: Area under the concentration-time curve of dabigatran in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
timeFrame: Up to 4 days
Other outcomes:
Locations:
city: Biberach
country: Germany
facility: Humanpharmakologisches Zentrum Biberach
Study officials:
References: