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Completed

NCT Number: 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

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.

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Humanpharmakologisches Zentrum Biberach

Biberach, 88397, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BI 690517 formulation 1

Drug

BI 690517 formulation 1

Other names: Vicadrostat

BI 690517 formulation 2

Drug

BI 690517 formulation 2

Other names: Vicadrostat

Probenecid

Drug

Probenecid

Other names: Probenecid Biokanol®

Primary outcomes

  1. 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)

    Time frame: Up to day 3.

    For the relative bioavailability of BI 690517.

  2. Cmax (maximum measured concentration of BI 690517 in plasma)

    Time frame: Up to day 3.

    For the relative bioavailability of BI 690517.

  3. AUC0-∞ (area under the concentration-time curve of BI 690517 in plasma over the time interval from 0 extrapolated to infinity)

    Time frame: Up to day 3.

    For the drug interaction of BI 690517 with probenecid.

  4. Cmax (maximum measured concentration of BI 690517 in plasma)

    Time frame: Up to day 3.

    For the drug interaction of BI 690517 with probenecid.

Secondary outcomes

  1. AUC0-∞ (area under the concentration-time curve of BI 690517 in plasma over the time interval from 0 extrapolated to infinity)

    Time frame: Up to day 3.

    For the relative bioavailability of BI 690517.

  2. 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)

    Time frame: Up to day 3.

    For the drug interaction of BI 690517 with probenecid.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study 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)

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Oct 18, 2024
Registry last updated
Jan 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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