A Study to Test How BI 3034701 is Taken up and Processed by the Body in Healthy Men With Normal Weight or Overweight

NCT07708493 | Not Yet Recruiting Phase 1

• 3 other identifiers: 1507-0012U1111-1335-92002026-525825-19
• Study Type: interventional
• Target: 8
• Locations: 0 countries
• Sites: N/A

Brief Summary

The main objectives of this trial are: To assess the mass balance (total recovery of \[14C\]-radioactivity) in urine, faeces, and expired air after a single subcutaneous dose of BI 3034701 (C-14) in healthy male trial participants.

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

• 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)

  Up to Day 50.

• 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)

  Up to Day 50.

• Fraction of [14C]-radioactivity excreted in expired air expressed as percentage of the administered dose over the time interval from 0 to the last quantifiable time point (feexpired air, 0-tz)

  Up to Day 49.

• Sum of feurine, 0-tz, fefaeces, 0-tz and feexpired air, 0-tz

  Up to Day 50.

Secondary Outcomes (4)

• Maximum measured concentration of [14C]-radioactivity in plasma

  Up to Day 22.

• Maximum measured concentration of BI 3034701 in plasma

  Up to Day 22.

• Area under the concentration-time curve of [14C]-radioactivity in plasma over the time interval from 0 to the last quantifiable time point (AUC0-tz)

  Up to Day 22.

• Area under the concentration-time curve of BI3034701 in plasma over the time interval from 0 to the last quantifiable time point (AUC0-tz)

  Up to Day 22.

Study Arms (1)

BI 3034701 (C-14)

EXPERIMENTAL

Drug: BI 3034701 (C-14)

Interventions

BI 3034701 (C-14) DRUG

BI 3034701 mixed with \[C-14\]BI 3034701

BI 3034701 (C-14)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy male trial participant according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure, pulse rate), 12-lead electrocardiogram, and clinical laboratory tests
• Age of 18 to 65 years (inclusive)
• Body mass index of 23.0 to 34.9 kg/m2 (inclusive)
• Signed and dated written informed consent in accordance with International Council for Harmonisation-Good Clinical Practice and local legislation prior to admission to the trial

You may not qualify if:

• Any finding in the medical examination (including blood pressure, pulse rate or electrocardiogram) 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 50 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Related Links

• Related Info

MeSH Terms

Interventions

Carbon-14

Central Study Contacts

Boehringer Ingelheim

CONTACT

1-800-243-0127; clintriage.rdg@boehringer-ingelheim.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2026
• First Posted: July 16, 2026
• Study Start: July 29, 2026
• Primary Completion (Estimated): October 14, 2026
• Study Completion (Estimated): October 14, 2026
• Last Updated: July 16, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share