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Completed

NCT Number: NCT05833035

A Study in Healthy Men to Test How BI 1291583 is Processed in the Body

The main objective of this trial is to

* Assess the mass balance and total recovery of [14C]-radioactivity in urine and faeces following a dose of BI 1291583 (C-14) * Provide plasma and urine samples for pharmacokinetic investigations * Provide plasma, urine, and faeces samples for metabolic profiling and structural identification of 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 kilogram per square meter (kg/m2, inclusive)
  • Signed and dated written informed consent in accordance with International Council for Harmonization - Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial

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 millimeter of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 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, fainting spells, or blackouts

Treatment and study plan

BI 1291583 mixed with [C-14] BI 1291583

Drug

BI 1291583 mixed with radioactive carbon labelled [C-14] BI 1291583

Primary outcomes

  1. Mass Balance and Total Recovery of [14C]-Radioactivity in Urine: Fraction of [14C]-Radioactivity Excreted in Urine Expressed as Percentage of the Administered Dose Over the Time Interval From 0 to the Last Quantifiable Time Point (Feurine, 0-tz)

    Time frame: Urine sampling intervals: Within 14 hours (h) prior and 0-4 , 4-8, 8-12, 12-24, 24-48, 48-72, 72-96, 96-120, 120-144, 144-168, 168-192, 192-216, 216-240, 240-264, 264-288, 288-312, 312-336h after intake of BI 1291583 (C14). Continues in description.

    Fraction of [14C]-radioactivity excreted in urine expressed as percentage of the administered dose over the time interval from 0 to the last quantifiable time point (feurine, 0-tz) is reported.

    Timeframe: After 336h, 24h interval urine sample collection was planned every 7 days starting on Day 21 until Day 43.

  2. Mass Balance and Total Recovery of [14C]-Radioactivity in Faeces: Fraction of [14C]-Radioactivity Excreted in Faeces Expressed as Percentage of the Administered Dose Over the Time Interval From 0 to the Last Quantifiable Time Point (Fefaeces, 0-tz)

    Time frame: All stools were collected prior and up to 336 hours (h) (sampling intervals 0-24, 24-48, 48-72, 72-96, 96-120, 120-144, 144-168, 168-192, 192-216, 216 -240, 240-264, 264-288, 288-312, 312-336 h) after intake of BI 1291583 (C14). Continues in description.

    Fraction of [14C]-radioactivity excreted in faeces expressed as percentage of the administered dose over the time interval from 0 to the last quantifiable time point (fefaeces, 0-tz) is reported.

    Timeframe: After 336h, 24h interval stools sample collection was planned every 7 days starting on Day 21 until Day 43.

Secondary outcomes

  1. Area Under the Concentration-time Curve of [14C]-Radioactivity ([14C]-BI 1291583-Equivalents (EQ)) in Plasma Over the Time Interval From 0 to the Last Quantifiable Time Point (AUC0-tz, [14C]-BI 1291583-EQ)

    Time frame: Within 4 hours prior and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 24, 48, 72, 120, 168, 216, 264, 336, 485, 653, 821, 989 hours after administration of BI 1291583 (C14).

    Area under the concentration-time curve of [14C]-radioactivity ([14C]-BI 1291583-EQ) in plasma over the time interval from 0 to the last quantifiable time point (AUC0-tz, [14C]-BI 1291583-EQ) is reported.

  2. Area Under the Concentration-time Curve of BI 1291583 in Plasma Over the Time Interval From 0 to the Last Quantifiable Time Point (AUC0-tz, BI 1291583)

    Time frame: Within 4 hours (h) prior and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 24, 48, 72, 120, 168, 216, 264, 336, 485, 653, 821, 989 h after administration of BI 1291583 (C14).

    Area under the concentration-time curve of BI 1291583 in plasma over the time interval from 0 to the last quantifiable time point (AUC0-tz, BI 1291583) is reported.

  3. Maximum Measured Concentration of [14C]-Radioactivity ([14C]-BI 1291583-Equivalents (EQ)) in Plasma (Cmax, [14C]-BI 1291583-EQ)

    Time frame: Within 4 hours prior and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 24, 48, 72, 120, 168, 216, 264, 336, 485, 653, 821, 989 hours after administration of BI 1291583 (C14).

    Maximum measured concentration of [14C]-radioactivity ([14C]-BI 1291583-EQ) in plasma (Cmax, [14C]-BI 1291583-EQ) is reported.

  4. Maximum Measured Concentration of BI 1291583 in Plasma (Cmax, BI 1291583)

    Time frame: Within 4 hours prior and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 24, 48, 72, 120, 168, 216, 264, 336, 485, 653, 821, 989 hours after administration of BI 1291583 (C14).

    Maximum measured concentration of BI 1291583 in plasma (Cmax, BI 1291583) is reported.

  5. Area Under the Concentration-time Curve of BI 1291583 Metabolites in Plasma Over the Time Interval From 0 to the Last Quantifiable Time Point (AUC0-tz, BI 1291583 Metabolites)

    Time frame: Within 4 hours (h) prior and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 24, 48, 72, 120, 168, 216, 264, 336, 485, 653, 821, 989 h after administration of BI 1291583 (C14).

    Area under the concentration-time curve of BI 1291583 metabolites in plasma over the time interval from 0 to the last quantifiable time point (AUC0-tz, BI 1291583 metabolites). AUC0-tz of the following BI 1291583 metabolites is reported:

    BI 1373234; CD 18507; CD 17849; CD 16785; BI 1321869.

  6. Maximum Measured Concentration of BI 1291583 Metabolites in Plasma (Cmax, BI 1291583 Metabolites)

    Time frame: Within 4 hours (h) prior and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 24, 48, 72, 120, 168, 216, 264, 336, 485, 653, 821, 989 h after administration of BI 1291583 (C14).

    Maximum measured concentration of BI 1291583 metabolites in plasma (Cmax, BI 1291583 metabolites). Cmax of the following metabolites is reported:

    BI 1373234; CD 18507; CD 17849; CD 16785; BI 1321869.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

A Phase I, Open-label, Single Dose, Mass Balance Trial to Investigate Metabolism and Pharmacokinetics of BI 1291583 (C-14) Administered as Oral Solution in Healthy Male Subjects

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 27, 2023
Registry last updated
Jan 21, 2026

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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