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)

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Probenecid; Drug: BI 690517 formulation 1; Drug: BI 690517 formulation 2

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Biberach, Germany, 88397
    • Humanpharmakologisches Zentrum Biberach

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BI 690517 formulation 1, then BI 690517 formulation 2, then Probenecid + BI 690517 formulation 2	Drug: Probenecid; Probenecid; Other Names: Probenecid Biokanol®; Drug: BI 690517 formulation 1; BI 690517 formulation 1; Other Names: Vicadrostat; Drug: BI 690517 formulation 2; BI 690517 formulation 2; Other Names: Vicadrostat
Experimental: BI 690517 formulation 2, then Probenecid + BI 690517 formulation 2, then BI 690517 formulation 1	Drug: Probenecid; Probenecid; Other Names: Probenecid Biokanol®; Drug: BI 690517 formulation 1; BI 690517 formulation 1; Other Names: Vicadrostat; Drug: BI 690517 formulation 2; BI 690517 formulation 2; Other Names: Vicadrostat
Experimental: Probenecid + BI 690517 formulation 2, then BI 690517 formulation 1, then BI 690517 formulation 2	Drug: Probenecid; Probenecid; Other Names: Probenecid Biokanol®; Drug: BI 690517 formulation 1; BI 690517 formulation 1; Other Names: Vicadrostat; Drug: BI 690517 formulation 2; BI 690517 formulation 2; Other Names: Vicadrostat

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2024
• Primary Completion (Actual): December 12, 2024
• Study Completion (Actual): January 7, 2025

Study Registration Dates

• First Submitted: October 17, 2024
• First Submitted That Met QC Criteria: October 17, 2024
• First Posted (Actual): October 18, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 7, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Gout Suppressants; Antirheumatic Agents; Uricosuric Agents; Probenecid
• Other Study ID Numbers: 1378-0025; 2024-513590-45-00 (Registry Identifier: CTIS); U1111-1307-2145 (Registry Identifier: WHO International Clinical Trials Registry Platform (ICTRP))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No