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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: BI 690517 formulation 1; Drug: BI 690517 formulation 2; Drug: Probenecid

• Registration Number: NCT06647810
• Lead Sponsor: Boehringer Ingelheim

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-17
• Study First Submitted QC: 2024-10-17
• Study First Posted: 2024-10-18
• Study Start: 2024-11-13
• Primary Completion: 2024-12-12
• Status Verified: 2025-01
• Study Completion: 2025-01-07
• Last Update Submitted: 2025-01-07
• Last Update Posted: 2025-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
BI 690517 formulation 1, then BI 690517 formulation 2, then Probenecid + BI 690517 formulation 2	BI 690517 formulation 1	-
BI 690517 formulation 1, then BI 690517 formulation 2, then Probenecid + BI 690517 formulation 2	BI 690517 formulation 2	-
BI 690517 formulation 1, then BI 690517 formulation 2, then Probenecid + BI 690517 formulation 2	Probenecid	-
BI 690517 formulation 2, then Probenecid + BI 690517 formulation 2, then BI 690517 formulation 1	BI 690517 formulation 1	-
BI 690517 formulation 2, then Probenecid + BI 690517 formulation 2, then BI 690517 formulation 1	BI 690517 formulation 2	-
BI 690517 formulation 2, then Probenecid + BI 690517 formulation 2, then BI 690517 formulation 1	Probenecid	-
Probenecid + BI 690517 formulation 2, then BI 690517 formulation 1, then BI 690517 formulation 2	BI 690517 formulation 1	-
Probenecid + BI 690517 formulation 2, then BI 690517 formulation 1, then BI 690517 formulation 2	BI 690517 formulation 2	-
Probenecid + BI 690517 formulation 2, then BI 690517 formulation 1, then BI 690517 formulation 2	Probenecid	-

Primary Outcome Measures

Name	Time	Method
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 drug interaction of BI 690517 with probenecid.
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 Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Humanpharmakologisches Zentrum Biberach; 🇩🇪 Biberach, Germany