Clinical trial NCT06647810: A Study in Healthy People to Test How 2 Different Formulations of BI 690517 Are Taken up in the Body and How Probenecid Influences the Amount of BI 690517 in the Blood
Official title: Relative Bioavailability of Two Different BI 690517 Formulations as Well as the Effect of Multiple Doses of Probenecid on the Single Dose Pharmacokinetics of BI 690517 Following Oral Administration in Healthy Male and Female Subjects (a Randomised, Open-label, Three-way Crossover Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2024-10-18
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This trial aims to test how two different formulations of BI 690517 are taken up by the body and how probenecid influences the amount of BI 690517 in the blood.


Eligibility criteria: Inclusion Criteria:

* Healthy male or female 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/m² (inclusive)
* Signed and dated written informed consent m accordance with International Conference of Harmonization-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial Further inclusion criteria apply.

Exclusion criteria:

* 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 45 to 90 bpm (beats per minute)
* 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 Further exclusion criteria apply.

Primary outcomes:
measure: AUC0-tz (area under the concentration-time curve of BI 690517 in plasma over the time interval from 0 to the last quantifiable data point)
timeFrame: Up to day 3.
measure: Cmax (maximum measured concentration of BI 690517 in plasma)
timeFrame: Up to day 3.
measure: AUC0-∞ (area under the concentration-time curve of BI 690517 in plasma over the time interval from 0 extrapolated to infinity)
timeFrame: Up to day 3.
measure: Cmax (maximum measured concentration of BI 690517 in plasma)
timeFrame: Up to day 3.
Secondary outcomes:
measure: AUC0-∞ (area under the concentration-time curve of BI 690517 in plasma over the time interval from 0 extrapolated to infinity)
timeFrame: Up to day 3.
measure: AUC0-tz (area under the concentration-time curve of BI 690517 in plasma over the time interval from 0 to the last quantifiable data point)
timeFrame: Up to day 3.
Other outcomes:
Locations:
city: Biberach
country: Germany
facility: Humanpharmakologisches Zentrum Biberach
Study officials:
References: