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Completed

NCT Number: NCT05515588

A Study in Healthy Men to Test How BI 690517 is Taken up and Handled by the Body

The trial is intended to investigate the basic pharmacokinetics, excretion pathways and metabolism of BI 690517 and its metabolites.

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

ICON

Groningen, 9728 NZ, Netherlands

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy male 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 in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial.

Exclusion criteria

Subjects will not be allowed to participate, if any of the following general criteria apply:

  • 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 millimetre(s) of mercury (mmHg), diastolic blood pressure outside the range of 45 to 90 mmHg, or pulse rate outside the range of 40 to 100 beats per minute (bpm).
  • 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.
  • Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders.
  • Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair).
  • Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders.
  • History of relevant orthostatic hypotension (including but not limited to a reduction in systolic BP of ≥20 mm Hg or in diastolic BP of ≥10 mm Hg within 3 minutes of standing during screening measurement associated with clinical symptoms), fainting spells, or blackouts.

Further exclusion criteria apply.

Treatment and study plan

BI 690517 (C-14)

Drug

BI 690517 (C-14)

Other names: Vicadrostat

BI 690517

Drug

BI 690517

Other names: Vicadrostat

Primary outcomes

  1. Part A: Fraction of [14C] radioactivity excreted into urine given as percentage of the administered dose in the time interval from 0 to last quantifiable time point (fe urine,0-tz )

    Time frame: Up to 22 days.

  2. Part A: Fraction of [14C] radioactivity excreted into feces given as percentage of the administered dose in the time interval from 0 to last quantifiable time point (fe feces, 0-tz)

    Time frame: Up to 22 days.

  3. Part B: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity after intravenous administration (AUC0-∞)

    Time frame: Up to 3 days.

  4. Part B: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity after oral administration (AUC0-∞)

    Time frame: Up to 3 days.

Secondary outcomes

  1. Part A: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable time point (AUC0-tz)

    Time frame: Up to 8 days.

  2. Part A: Maximum measured concentration of the analyte in plasma (Cmax)

    Time frame: Up to 8 days.

  3. Part B: Maximum measured concentration of the analyte in plasma (Cmax)

    Time frame: Up to 3 days.

  4. Part B: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable time point (AUC0-tz)

    Time frame: Up to 3 days.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

A Phase I, Open-label Trial to Investigate Metabolism, Pharmacokinetics (Following a Mass Balance Design) and Absolute Bioavailability of BI 690517 (C-14) After Oral and Intravenous Administration in Healthy Male Subjects

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Aug 25, 2022
Registry last updated
Sep 20, 2024

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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