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

A Phase I, Open-label, Single-dose, Single-arm Trial to Investigate Metabolism and Pharmacokinetics of BI 3034701 (C-14) Administered to (Otherwise) Healthy Male Volunteers With Normal Body Weight or Overweight

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07708493

Enrollment

Registered

2026-07-16

Start date

2026-08-24

Completion date

2026-10-14

Last updated

2026-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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.

Interventions

DRUGBI 3034701 (C-14)

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

1. 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 2. Age of 18 to 65 years (inclusive) 3. Body mass index of 23.0 to 34.9 kg/m2 (inclusive) 4. 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

Exclusion criteria

1. Any finding in the medical examination (including blood pressure, pulse rate or electrocardiogram) deviating from normal and assessed as clinically relevant by the investigator 2. 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) 3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance 4. Any evidence of a concomitant disease assessed as clinically relevant by the investigator 5. Further

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.

Countries

Hungary

Contacts

CONTACTBoehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com1-800-243-0127

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 10, 2026