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NCT Number: NCT07837648

A Study to Test How Much BI 3034701 Gets Into the Blood in Healthy People When Given in Two Different Ways

The aim of the trial is to investigate relative bioavailability of BI 3034701 treatment T vs. BI 3034701 treatment R.

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

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 or female trial participant 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) at screening
  • Body mass index (BMI) of 20.0 to 32.0 kg/m^2 (inclusive) at screening
  • Signed and dated written informed consent in accordance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) and local legislation prior to admission to the trial
  • Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly.

Exclusion criteria

  • Any finding in the medical examination (including BP, PR or ECG) deviating from 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 bpm
  • Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
  • Further exclusion criteria apply.

Treatment and study plan

BI3034701 formulation B

Drug

BI3034701 formulation B (reference treatment)

BI3034701 formulation C1

Drug

BI3034701 formulation C1 (test treatment)

Primary outcomes

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

    Time frame: Up to 19 days.

  2. Maximum measured concentration of the analyte in plasma (Cmax)

    Time frame: Up to 19 days.

    Highest observed plasma concentrations within the time interval.

Secondary outcomes

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

    Time frame: Up to 19 days.

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

Relative Bioavailability of Two Different BI 3034701 Treatments Following Subcutaneous Administration in Healthy Male and Female Participants (an Open-label, Randomised, Single-dose, Two-period, Two-sequence, Crossover Trial)

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Sep 23, 2026
Registry last updated
Sep 23, 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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