A Study in Healthy Men to Test How BI 1291583 is Taken up by the Body

NCT06166992 | Completed Phase 1

• 2 other identifiers: 1397-00262023-505683-11-00
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of this trial is to investigate the absolute bioavailability of BI 1291583 (test treatment T, not radio-labelled) compared with BI 1291583 (C-14) (reference treatment R).

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Area under the concentration-time curve of the analyte over the time interval from 0 extrapolated to infinity (AUC0-∞)

  Up to 10 days

Secondary Outcomes (2)

• Maximum measured concentration of the analyte in plasma (Cmax)

  Up to 10 days

• 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)

  Up to 10 days

Study Arms (2)

BI 1291583 alone (not radio-labelled, low dose) then [14C]-BI 1291583 (radio-labelled)

EXPERIMENTAL

Drug: BI 1291583; Drug: [14C]-BI 1291583

BI 1291583 alone (not radio-labelled, high dose) then [14C]-BI 1291583 (radio-labelled)

EXPERIMENTAL

Drug: BI 1291583; Drug: [14C]-BI 1291583

Interventions

BI 1291583 DRUG

BI 1291583

Also known as: Verducatib

BI 1291583 alone (not radio-labelled, high dose) then [14C]-BI 1291583 (radio-labelled); BI 1291583 alone (not radio-labelled, low dose) then [14C]-BI 1291583 (radio-labelled)

[14C]-BI 1291583 DRUG

\[14C\]-BI 1291583

Also known as: Verducatib

BI 1291583 alone (not radio-labelled, high dose) then [14C]-BI 1291583 (radio-labelled); BI 1291583 alone (not radio-labelled, low dose) then [14C]-BI 1291583 (radio-labelled)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 ICH-GCP and local legislation prior to admission to the trial.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

ICON

Groningen, 9728 NZ, Netherlands

Location

Related Links

• Related Info

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2023
• First Posted: December 12, 2023
• Study Start: December 12, 2023
• Primary Completion: February 7, 2024
• Study Completion: February 7, 2024
• Last Updated: August 13, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)