How BI 3034701 gets into the blood when given in two different forms in healthy adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 1, interventional study compares two BI 3034701 formulations (II and C1) to see how much the drug enters the blood after administration in healthy volunteers. Participants are healthy adults aged 18 to 55, with specific BMI criteria and medical screening, and must use effective birth control if applicable. The study is sponsored by Boehringer Ingelheim with sites at Quotient Sciences in Nottingham. The primary goal is to characterize relative bioavailability between the two formulations, which informs dosing strategies for future studies. The trial design emphasizes safety monitoring and pharmacokinetic measurements in a controlled setting.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. 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
2. Age of 18 to 55 years (inclusive) at screening
3. Body mass index (BMI) of 20.0 to 32.0 kg/m\^2 (inclusive) at screening
4. 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
5. 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:

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

Where it's running

• Quotient Sciences
  Nottingham, United Kingdom Recruiting

Study contacts

• Study coordinator: Boehringer Ingelheim
• Email: clintriage.rdg@boehringer-ingelheim.com
• Phone: 1-800-243-0127

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.