Phase 1
N=8
A Study in Healthy Men to Test How BI 1291583 is Processed in the Body
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT05833035 ↗Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Jan 2026
Primary outcome: Primary: 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) — 26.0 percentage of administered dose
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- BI 1291583 mixed with [C-14] BI 1291583 (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Jul 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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) |
26.0 | — |
| PRIMARY 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) |
61.4 | — |
| SECONDARY 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) |
1730 | — |
| SECONDARY 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) |
139 | — |
| SECONDARY Maximum Measured Concentration of [14C]-Radioactivity ([14C]-BI 1291583-Equivalents (EQ)) in Plasma (Cmax, [14C]-BI 1291583-EQ) |
6.58 | — |
| SECONDARY Maximum Measured Concentration of BI 1291583 in Plasma (Cmax, BI 1291583) |
1.90 | — |
| SECONDARY 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) |
157; 159; 167; 48.3; 5280 | — |
| SECONDARY Maximum Measured Concentration of BI 1291583 Metabolites in Plasma (Cmax, BI 1291583 Metabolites) |
1.48; 0.944; 0.330; 0.391; 12.2 | — |
Summary
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
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05833035). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.