NCT05833035 is a Phase 1 clinical trial of BI 1291583 mixed with [C-14] BI 1291583 in Healthy, sponsored by Boehringer Ingelheim.

Who is sponsoring NCT05833035?

NCT05833035 is sponsored by Boehringer Ingelheim.

What drugs are being tested in NCT05833035?

Interventions in NCT05833035: BI 1291583 mixed with [C-14] BI 1291583.

Is NCT05833035 still recruiting?

NCT05833035 is currently completed. Last updated 21 January 2026.

Are results published for NCT05833035?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2026-01-21 · How we verify

NCT05833035

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 1 Results posted Last updated 21 January 2026

What this trial tests

Phase 1 trial testing BI 1291583 mixed with [C-14] BI 1291583 in Healthy in 8 participants. Completed in 5 July 2023.

Timeline

24 April 2023

Primary endpoint
5 July 2023

5 July 2023

Quick facts

Lead sponsor	Boehringer Ingelheim
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	8
Start date	24 April 2023
Primary completion	5 July 2023
Estimated completion	5 July 2023
Sites	1 location across Netherlands

Drugs / interventions tested

BI 1291583 mixed with [C-14] BI 1291583 — full drug profile →

Conditions studied

Healthy — all drugs for Healthy →

Sponsor

Boehringer Ingelheim — full company profile →

Who can join

Adults 18 to 55, male only, with Healthy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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) Primary · 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.

Group	Value	95% CI
BI 1291583 (C-14)	26.0	± 12.9

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) Primary · 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.

Group	Value	95% CI
BI 1291583 (C-14)	61.4	± 13.2

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) Secondary · 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.

Group	Value	95% CI
BI 1291583 (C-14)	1730	± 16.1

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) Secondary · 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.

Group	Value	95% CI
BI 1291583 (C-14)	139	± 19.7

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

Group	Value	95% CI
BI 1291583 (C-14)	6.58	± 14.4

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

Group	Value	95% CI
BI 1291583 (C-14)	1.90	± 23.8

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) Secondary · 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.

CD 17849

Group	Value	95% CI
BI 1291583 (C-14)	157	± 47.8

CD 18507

Group	Value	95% CI
BI 1291583 (C-14)	159	± 37.3

CD 16785

Group	Value	95% CI
BI 1291583 (C-14)	167	± 47.6

BI 1373234

Group	Value	95% CI
BI 1291583 (C-14)	48.3	± 33.2

BI 1321869

Group	Value	95% CI
BI 1291583 (C-14)	5280	± 79.4

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

CD 17849

Group	Value	95% CI
BI 1291583 (C-14)	1.48	± 44.9

CD 18507

Group	Value	95% CI
BI 1291583 (C-14)	0.944	± 28.3

CD 16785

Group	Value	95% CI
BI 1291583 (C-14)	0.330	± 43.6

BI 1373234

Group	Value	95% CI
BI 1291583 (C-14)	0.391	± 26.3

BI 1321869

Group	Value	95% CI
BI 1291583 (C-14)	12.2	± 26.2

Adverse events — posted to ClinicalTrials.gov

Time frame: From first administration of BI 1291583 (C14) until the end of the residual effect period, up to 28 days.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

BI 1291583 (C-14)

Serious: 0/8 (0%)

Deaths: 0/8

Other adverse events (7 terms — click to expand)

Reaction	System	BI 1291583 (C-14)
Dizziness	Nervous system disorders	—
Headache	Nervous system disorders	—
Presyncope	Nervous system disorders	—
Syncope	Nervous system disorders	—
Abdominal distension	Gastrointestinal disorders	—
Abdominal pain	Gastrointestinal disorders	—
Micturition urgency	Renal and urinary disorders	—

Data from ClinicalTrials.gov NCT05833035 adverse events section.

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Healthy

Currently open trials in the same condition.

NCT06707207 — Predicting Future Errors During Skill Performance · recruiting
NCT07169630 — PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI) · Phase 1 · recruiting
NCT07499414 — The Effects of the Bile Acid Supplement, 7-keto Lithocholic Acid, on Human Gut Microbiota and Risk Factors for Disease. · NA · recruiting
NCT07496697 — Effects of Electroacupuncture at NP82 and SP15 on Bowel Motility in Healthy Subjects · NA · recruiting
NCT06431932 — Pilot Trial of Fisetin in Healthy Volunteers and Older Patients With Multimorbidity · Phase 1, PHASE2 · recruiting

Other Boehringer Ingelheim trials

Trials by the same sponsor.

NCT07044700 — Real-world Comparative Effectiveness and Safety of Jardiance in Chinese Patients With Heart Failure of Reduced Ejection · not yet recruiting
NCT07047508 — Real-world Study to Describe the Effectiveness and Safety Outcomes of Jardiance in Chinese Patients With Heart Failure a · not yet recruiting
NCT07366034 — A Study to Find Out How Nerandomilast is Tolerated, Handled by the Body, and if it Helps Children and Adolescents With I · Phase 3 · not yet recruiting
NCT07531628 — A Study to Test How Verducatib is Taken up in the Body of Healthy Chinese Participants · Phase 1 · not yet recruiting
NCT07497087 — A Study to Test Whether Nerandomilast Helps People With Systemic Sclerosis · Phase 3 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05833035 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Boehringer Ingelheim
Last refreshed: 21 January 2026

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05833035.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing