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

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)

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06647810

Enrollment

Registered

2024-10-18

Start date

2024-11-13

Completion date

2025-01-07

Last updated

2025-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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.

Interventions

DRUGBI 690517 formulation 1

BI 690517 formulation 1

DRUGBI 690517 formulation 2

BI 690517 formulation 2

DRUGProbenecid

Probenecid

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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)	Up to day 3.	For the relative bioavailability of BI 690517.
Cmax (maximum measured concentration of BI 690517 in plasma)	Up to day 3.	For the relative bioavailability of BI 690517.
AUC0-∞ (area under the concentration-time curve of BI 690517 in plasma over the time interval from 0 extrapolated to infinity)	Up to day 3.	For the drug interaction of BI 690517 with probenecid.

Secondary

Measure	Time frame	Description
AUC0-∞ (area under the concentration-time curve of BI 690517 in plasma over the time interval from 0 extrapolated to infinity)	Up to day 3.	For the relative bioavailability of BI 690517.
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)	Up to day 3.	For the drug interaction of BI 690517 with probenecid.

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026