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NCT Number: NCT07708493

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

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.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • Further exclusion criteria apply.

Treatment and study plan

BI 3034701 (C-14)

Drug

BI 3034701 mixed with [C-14]BI 3034701

Primary outcomes

  1. 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)

    Time frame: Up to Day 50.

  2. 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)

    Time frame: Up to Day 50.

  3. 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)

    Time frame: Up to Day 49.

  4. Sum of feurine, 0-tz, fefaeces, 0-tz and feexpired air, 0-tz

    Time frame: Up to Day 50.

Secondary outcomes

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

    Time frame: Up to Day 22.

  2. Maximum measured concentration of BI 3034701 in plasma

    Time frame: Up to Day 22.

  3. 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)

    Time frame: Up to Day 22.

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

    Time frame: Up to Day 22.

Study contacts

Contact information is provided by the study sponsor or research team.

Boehringer Ingelheim

CONTACT

[email protected]

1-800-243-0127

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 16, 2026
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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