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

ConditionHealthy
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age18-65
SponsorBoehringer Ingelheim

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • BI 3034701 (C-14)

Treatment groups

8 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators